Aspen has a proud heritage dating back more than 160 years and is committed to sustaining life and promoting healthcare through increasing access to its high quality affordable medicines and products. Aspen has a market capitalisation of approximately US$10 billion, is the largest pharmaceutical company listed on the JSE Limited (share code: APN) and rank...
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OBJECTIVE OF ROLE
- To support the SA Commercial Business to realize the commercial strategy and to achieve the annual targeted growth and revenue through successful new product introductions and maintenance of current product portfolio in the region, by ensuring successful Marketing Authorisation and variation approval from the Regulatory Authorities within the committed timeframe. The role undertakes responsibility for compliance with the Regulatory requirements for the New Product Launch Pipeline and the existing product portfolio in the region, through the successful completion of assigned activities according to the Regulatory plan.
- Perform regulatory functions to secure Marketing Authorisation, and life-cycle management of the dossier post registration, through effective dealings with internal and external customers and regulatory authorities.
- Contribute special expertise cross functionally and provide technical and procedural training to the department and junior personnel. Peer review junior personnel’s work and provide guidance as required.
KEY RESPONSIBILITIES
Financial
- Effective utilization of resources to keep procedures cost effective
Customer
- Display a professional attitude when responding to customers
- Propose, develop and update methods to improve customer services
- Effective liaison and communication with internal and external customers, including but not limited to Regulatory Authorities, External consultants and Agents, Quality Assurance, Project managers, Artwork, New Product Launches, Manufacturing Sites, Pharmacovigilance, Medical Information, AGI, APTL,
Quality management
- Ensure systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOP’s.
Due diligence
- Perform due diligence on new IP identified for licensing/acquisition to identify deficiencies in the IP relating to SAHPRA and SADC member states laws and regulations, in compliance with timelines in licensor/purchaser agreements
- Raise all risks and critical issues with line manager at DD stage before issuing DD report
- Request CCDS/PI, frills, samples, etc. from the relevant departments as per process, within specified timelines
- Follow up with stakeholders on DD requests until finalization of outstanding matters, ensuring a quality and compliant submission.
New registration applications
- Use eCTD publisher and dedicated I-drive to compile quality dossiers which are compliant with country specific requirements, guidelines, regulations, and internal departmental procedures, within the allocated timelines, ensuring smooth progression to
Marketing Authorisation
- Raise any minor additional data requirements identified at compilation stage so as not to compromise proposed submission date
- Ensure required fee is paid to the Authority
- Ensure relevant support personnel are asked timeously to prepare the electronic or hard copy submission, over-see and review such activities
- Ensure proof of receipt from relevant Authority is received and recorded
- Update and maintain all appropriate trackers, databases and systems as required to ensure visibility and accurate reporting
- Attend to action items in electronic QMS to ensure compliance with completion/closeout timelines.
Response to screening outcomes and recommendations
- Compile and submit compliant responses to screening outcomes from regulatory authorities by requesting additional data/frills/samples
- Over-see the compilation of post-screening copies, take responsibility and sign relevant documentation after verifying quality/compliance of the response
- Over-see completion of administrative functions as per departmental procedures
- Compile and submit compliant responses to recommendations from the following Units, being aware of communicating risks to line manager:
- P&A Unit
- Inspectorate Unit
- Names & Scheduling Unit
- P&A Variations
- Marketing Authorisation Renewals
- Action and close out electronic QMS items
- Over-see completion of administrative functions as per departmental procedures
Registration
- Ensure new Marketing Authorisations are up to date with all pre-registration activities, including recommendations from all relevant Authority committees or units.
- Ensure that all labelling components are updated with the registration details as per departmental procedures
- Ensure that translated labelling text is available if required as per country specific requirements
- Ensure that accurate labelling text is provided to the Artwork Department via the Artwork Management system, for implementation in the market
- Consider impact of registration details on shared packs
- Receive and review registration certificate for errors, and arrange correction
- Check for post-registration variations and notify line manager of these as per process
- Action and close out electronic QMS items
Over-see completion of administrative functions as per departmental procedures
- Dossier maintenance (variations)
- Submit Variations to regulatory authorities in accordance with laws and regulation
- Ensure required fee is paid to the Authority
- Receive and distribute approval documentation from regulatory authorities as per departmental procedures
- Update and maintain all relevant trackers, databases and systems
- Action and close-out electronic QMS items
- Over-see completion of administrative functions as per departmental procedures
Projects
- Coordinate and manage projects as required
Training
- Provide technical and procedural training to the department in line with development needs
- Provide one on one training and coaching to less experienced staff and reviewing their work as required
Requirements
EDUCATIONAL REQUIREMENTS
- Matric/Grade 12
- Bachelor of Pharmacy degree or equivalent.
KNOWLEDGE & EXPERIENCE REQUIREMENTS
- Minimum 2 years’ experience in a Regulatory Affairs environment, including compilation and submission of new product applications and variations in accordance with the latest requirements.
- 1-2 years’ experience within the pharmaceutical industry in a Production/Quality/Clinical environment a distinct advantage
- A solid understanding of The Medicines and Related Substance Act Act 101 of 1965 and Regulations, and the Acts and Regulations of SADC member states
- Comprehensive knowledge of SAHPRA Guidelines, and those of SADC member states’ where relevant Knowledge of principles governing regulatory requirements such as ICH and WHO Technical knowledge of the CTD, eCTD and SADC member states’ dossier formats where applicable
- Knowledge of project management principles
SOFT SKILLS REQUIREMENTS
- Integrity. Good work ethic and ability to meet deadlines
- Good interpersonal skills
- Information seeking
- Business analysis and financial skills
- Problem-solving and good judgment
- Accuracy and Attention to detail
- Time Management
- Resource efficiency
- Risk management
- Responsibility and accountability
- Initiative
- Results oriented
- Systems thinking
- Planning and organisational skills
- Focused
- Informal communications skills
- Active listening skills
- Writing skills
- Presentation skills
- Empathy
- Flexibility and tolerance for ambiguity
- Transition management
- Capacity for and resistance to stress
- Ability to work under pressure
- Perseverance and tenacity
- Technical / professional knowledge
- Industry knowledge
- Curiosity / learning agility
- Self-awareness
- High standards
COMPUTER SKILLS REQUIRED
- The applicant must be proficient in the various applications (Word, Excel and PowerPoint) within the Microsoft Office bundle.
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OBJECTIVE OF ROLE
- The role undertakes responsibility for the pharmaceutical tasks within the quality management systems (QMS) function of the Quality department for Pharmacare Limited, ensuring QMS and company compliance with sound quality assurance (QA) principles and requirements, Aspen Group and Third-Party Alliance partner policies and procedures and in accordance with Good ‘X’ Practice (GxP) guidelines, The Pharmacy Act, Act 53 of 1974 as amended, the Medicines and Related Substances Act, Act 101 of 1965 as amended, and any other relevant legislation and guidelines relating to the import, export, manufacture, packing, testing, warehousing and distribution of medicines in South Africa and the Southern African Development Community (SADC), thereby ensuring that the products meet the intended quality, safety and efficacy standards and requirements as required of the marketing authorisation (MA) holding entity, Pharmacare Limited.
- To perform pharmaceutical tasks within the Quality department under the direction of the Quality Lead - Quality Management Systems. This includes the Quality Management System, Product Quality Review (PQR), Waste Management, Product Quality Complaints, Inspections, Self-Inspections, Trend Analysis, Risk Management, Training, and associated functions as per GxP and company Standard Operating Procedures
KEY RESPONSIBILITIES
- General Operational Activities
- Execute daily tasks according to the relevant standard operating procedures and work instructions.
- Adhere to agreed Key Performance Indicators (KPIs)
- Support the continuous development and improvement of the Quality function while upholding the Aspen core values
- Operate computer systems by capturing data, printing standard reports, etc.
- Perform reconciliations of data.
- Update and maintain systems, databases and trackers
- Generate reports as per instruction.
- Collate data for ad hoc requests
- Verify and interpret the accuracy of data and audit documentation.
- Obtain the necessary signatures for all relevant documentation
- Manage and utilise resources effectively to keep processes cost effective
- Provide quality support for the SA and SADC Commercial, Supply Chain, Value Chain, and enablement functions (e.g. Regulatory, Finance), as it relates to QMS matters
- Maintain good relations and communications with all members of the team and respond politely and in a timely fashion to internal and external customers.
- Work with all members of staff to maintain and develop the positive progressive culture within Aspen.
- Display a professional attitude when responding to customers and responding to enquiries in a timely manner
- Manage projects as per guidance from the line manager and within agreed timeframes
- Provide regular feedback on progress of projects and highlight any issues that require the line manager’s attention
- Adhere to company policies and procedures
- Participate in training programmes
- Keep abreast of developments in best practice, and all QMS related activities
- Maintain a high and up-to-date level of QMS and therapy area knowledge by attending conferences, training courses, and reading relevant medical and scientific literature
- Any other duties as assigned by line manager or head of department
- Maintain templates and lists
- Maintain accurate filing and retrieval of documentation
- Perform any other administrative tasks relating to your work as and when required
Quality Management System
- Responsible for quality management system activities, including change controls, deviations, corrective and preventative actions (CAPAs), quality risk management and assessments, customer product quality complaints, annual product quality reviews, training, product recalls/withdrawals, self-inspections, internal/external audits of Pharmacare, regulatory intelligence and documentation such as standard operating procedures (SOPs)/work instructions and reports.
- Compile, review and update SOPs and related documentation (e.g. Work Instructions, standard forms, trackers and all relevant Quality Management System documents) related to work function to ensure compliance with the relevant Policies, Guidelines, Regulations and Contractual requirements.
- Identify and introduce new policies and procedures where necessary
- Review of processes (SOP’s, Work Instructions, etc) to ensure continuous improvement and the updating of procedures/work instructions to align accordingly
- Write, review and approve quality documentation, including reports, and eQMS records.
- Assist with product recalls/withdrawals including mock recalls.
- Write, review, approve and update standard operating procedures, work instructions and associated documents.
- Respond to enquiries in a timely manner, giving advice on quality requirements.
- Assist with monitoring and reviewing the QMS, including change controls, deviations, investigations, CAPAs, effectiveness checks, quality risk assessments, product quality complaints, product quality reviews, self- inspections, external audit reports, regulatory inspections and SOPs.
- Conduct/assist with self-inspections including compiling the annual self-inspection schedule, compile the self-inspection reports, follow up on the progress of self-inspection findings, and corrective and preventative actions.
- Participate in regulatory inspections.
- Deliver internal training e.g. GxP training and SOP training
- Assist with root cause analyses, risk assessments, risk management and risk reporting
- Comply with Good Manufacturing Practice (GMP), Good Wholesaling Practice (GWP) and Good Distribution Practice (GDP) guidelines and regulations.
- Collaborate with the local Regulatory and Operations teams to ensure the appropriate flow of information and decisions.
- Collaborate with Pharmacovigilance, Medical Information and Compliance, Intellectual Property and Dossier Management, and other operational departments to always ensure audit/inspection readiness.
- Collaborate with the regional and global product quality teams, to seek advice, inputs and guidance, and work on any regional or cross-functional projects.
- Compile the quality trend report and quality systems management review report under the guidance of the Quality Lead – Quality Management Systems.
- Participate in QMS monthly and annual reviews
- Compile and update the site master file and quality manual.
- Renew the licenses for the marketing authorisation holder i.e., import and export licence and medical device establishment licence.
- Complete the risk and impact assessments of new/updated regulations, guidelines, policies, regulatory authority communications.
- Inform internal and external customers of new/updated regulations, guidelines, policies, and regulatory authority communications.
- Ensure ongoing Quality and QMS requirements and commitments, as per the latest regulatory authority and PICS and other relevant guidance, is fulfilled and maintained
- Change ownership for all assigned change controls and completion of action items
- Complete Change control, Change action, Deviation, Investigation, CAPA, Effectiveness check, and Audit Finding records in accordance with the requirements of the QMS Due dates
Product Quality Reviews
- Compile the PQR schedule based on a risk assessment.
- Compile PQR reports based on raw data provided by the manufacturer (when required).
- Review PQR reports compiled by the Business Supporter/Quality Management Systems Officer for accuracy and compliance to the dossier, technical quality agreement and GMP requirements.
- Identify risks from PQR reviews, escalate such risks to management, and perform risk assessments where required.
- Identify appropriate CAPAs from PQR reviews, notify the relevant department/s to implement the CAPAs and ensure effectiveness check/s are performed.
- Propose and develop methods for improving PQRs.
- Maintain the PQR budget based on schedule
Product Quality Complaints
- Assist with customer product quality complaints in a timely and professional manner.
- Review the accuracy of customer product quality complaints recorded in the electronic quality management system (eQMS) within specific timelines.
- Liaise with the manufacturing sites to ensure that investigations are completed as per specific timelines and requirements.
- Obtain Pharmacovigilance evaluations for Customer product quality within the required timeframes.
- Perform a reconciliation of customer product quality complaints with internal and external parties.
- Review customer product quality complaint investigation reports
- Evaluate corrective and preventative actions, that have been identified to address customer product quality complaints, for relevance and effectiveness. Identify and escalate any critical concerns that may result in a product recall/withdrawal to senior management.
- Perform a trend analysis of customer product quality complaints to ensure that the appropriate actions are taken.
- Initiate discussions with the relevant stakeholders where trends are observed with regards to customer product quality complaints to implement corrective and preventative actions.
- Generate reports of overdue complaint records and follow up with the manufacturing sites/s every two weeks.
- Assist in developing a robust internal process to handle customer product quality complaints and propose and develop methods for improving customer services.
- Train the relevant employees and third parties on the correct procedures to follow when managing customer product quality complaints.
- Maintain courier costs for complaint and replacement samples
Waste Management
- Facilitate the waste management process (sample destruction) under the guidance of the Quality Lead – Quality Management Systems
- Implement written procedures describing the process for waste management.
- Coordinate product waste destruction, in consultation with the Quality Lead – Quality Management Systems for products/samples
- Liaise with the waste destruction service provider/s relating to waste management requirements
Continuous Improvement
- Identify gaps within current processes, investigate the gaps and propose ways to close the gaps
- Identify ways to streamline processes, resulting in greater efficiency and productivity
- Generate accurate and easily retrievable information and statistics for the department
Requirements
EDUCATIONAL REQUIREMENTS
- Relevant Pharmacy Degree
- Registered with the South African Pharmacy Council
KNOWLEDGE & EXPERIENCE REQUIREMENTS
- 3 to 5 years’ experience in Quality in a GxP-accredited pharmaceutical environment, preferably in a marketing authorisation holding, distributor, wholesaler or manufacturing facility
- Experience in Quality Management Systems required
- Experience in medicine legislation, related guidelines and codes of practice
- Experience in Good Manufacturing Practice and Good Documentation Practices
- Computer skills in MS Office suite and Adobe required
- A solid understanding of The Medicines and Related Substances Act 101 of 1965 (as amended) and regulations (South Africa)
- An understanding of SADC and member states’ laws and regulations
- Deep technical knowledge of cGMP, cGDP, cGWP, ICH and PIC/s requirements
- Comprehensive knowledge of SAHPRA and SADC Guidelines
- Experience with electronic quality management systems, and document management systems
SOFT SKILLS REQUIREMENTS
- Results and performance driven
- Sense of urgency – responding to issues and opportunities in a timely manner (Time management)
- Intellectual curiosity – willing to suggest and try new ideas
- Positive attitude and proactive approach to business tasks
- Excellent interpersonal skills
- The ability to communicate effectively (written and verbal) is essential
- Information seeking, effective problem solving and decision making
- Strong capabilities in logical reasoning
- A solutions provider
- Ability to work in a fast-paced international environment
- Accuracy and attention to detail
- Manage evolving deadlines effectively with regular feedback, updates
- Integrity
- Work ethic
- Ability to meet deadlines
- Analytical skills
- Service orientation
- Initiative
- Confidentiality
- Empathy
- Patience
- Influence
- Effective planning and organisation skills and ability to prioritize
- Customer focused – understands the needs and priorities of customers
- Project management skills
- Time Management
- Strong Administrative Skills
- Ability to multitask and strong proven follow-up skills is a requirement.
- Planning, organizing and communication skills.
- Excellent communication skills, including verbal and written proficiency in the English language
COMPUTER SKILLS REQUIRED
- The applicant must be proficient in the various applications (Word, Excel and PowerPoint) within the Microsoft Office bundle.
Apply by
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OBJECTIVE OF ROLE
- To assist in an administrative/commercial/ secretarial function Back Shop Marketing Team.and providing comprehensive support to the division for their optimal output. Serve as interface between the department and internal and external customers.
KEY RESPONSIBILITIES
- Providing comprehensive admin support to the Backshop division to ensure all internal administrative processes are running smoothly and policies are adhered to.
- Preparing minutes for all team meetings as required by the division
- Raising requisitions for all divisional expenses on SAP and maintaining a monthly recon
- Provide support services for Aspen and Backshop Team internal and external meetings, functions, and conferences (e.g. Cycle meeting, Sales conference, awareness days)
- Support for Backshop Marketing promotions and programs
- New Product launch event management and support for launches
- Booking of venues and ensuring reservations and payments are in place prior to the function. This includes managing refunds and credits.
- Loading material on the Veeva and assisting Brand Managers with Brand promotional materials
ADDITIONAL DUTIES
- Management of Reception area and Building requirements, including supplies
- Management of cleaning staff
Requirements
EDUCATIONAL REQUIREMENTS
- Matric / Grade 12
- Secretarial diploma
- Sales / Marketing diploma an advantage
KNOWLEDGE & EXPERIENCE REQUIREMENTS
- 1-year General divisional assistant experience an advantage
- Computer literate: MS Office/Excel/Word
- SAP packages an advantage
- General administration experience
- Customer service experience essential
- Co-ordinating / multi-tasking for more than one manager
- Working knowledge of business principles
- Experience of internal systems and policies
SOFT SKILLS REQUIREMENTS
- Effective planning, organising and coordinating.
- Effective analytical, problem solving & decision-making skills.
- Strong listening skills
- Results driven.
- Independent and self-directed individual that can drive execution.
- Effective interpersonal skills
- The ability to communicate effectively (written and verbal) is essential.
- Attention to detail.
- Project management skills
- Ability to think strategically and innovatively.
- Time management crucial & conflict resolution approach
- Report writing and communication skills.
- Service orientated.
- Accuracy, initiative, confidentiality, empathy, customer focus, patience, logical thinking, information seeking and cultural sensitivity.
COMPUTER SKILLS REQUIRED
- The applicant must be proficient in the various applications (Word, Excel and PowerPoint) within the Microsoft Office bundle.
go to method of application »
KEY RESPONSIBILITIES
Financial
- Project management of contractual and financial aspects of all medical writing projects and the effective utilisation of resources to keep processes cost effective.
- Identification of project challenges to departmental line management and the financial impact thereof.
Project Management
- Act in the capacity of project manager/lead for medical writing projects. This may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues, and other duties as assigned.
- Project management of contractual and financial aspects to be performed with management where necessary.
- Serve as the Medical Writing representative to provide proactive support for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Identify any potential project challenges to departmental line management and project leader, including changes in project plan, timeline or out of scope requests, and suggest possible resolution options.
- Coordinate and conduct interdepartmental team review and sign-off of document deliverables according to Pharmacare guidelines/SOPs.
- Coordinate production and distribution of draft and final documents to regulatory teams. Ensure that all work is complete and of high quality prior to team distribution.
- Attend internal and technical team meetings as required.
- Assist management as needed with preparation of resourcing estimates for potential new medical writing projects
- Proactively engage with other departmental resources where necessary to ensure that information/documentation requests are delivered in a professional and timeous manner.
Medical Writing Accountabilities
- Ensure defined framework as set by PV Lead, RA Manager: Safety, Quality and Compliance, or Head of Department are executed within the specified timelines.
Write clinical documents for submission to regulatory authorities, including but not limited to:
- clinical overviews and summaries
- clinical expert statements
- interim and final clinical study reports
- integrated summaries of safety and efficacy
- nonclinical overviews and summaries
- Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.
Ensure document content and style adheres to FDA/EMA/SAHPRA or other appropriate regulatory guidelines, and complies with departmental and corporate SOPs and style guidelines
- Perform literature searches/reviews to obtain background information and training for development of documents
- Prepare country specific packs for submission of safety variations within ZA and other territories
- Assist in the assessment of clinical and nonclinical documentation with regards to its suitability for supporting new marketing authorisation applications (MAA) or new indications.
- Preparation of aggregate safety reports including but not limited to PSURs, PBRERs and Addendum Safety Reports.
- Preparation of Risk Management Systems including but not limited to Risk Management Plans, Healthcare Professional Letters and Risk Communication Plans.
- Request for Information from Competent Regulatory Authorities (CRAs)
- Manage safety related requests from regulatory agencies and Aspen Affiliates to ensure any requests are answered fully and promptly.
- Assessment of local PI/PIL for inclusion of the validated signal.
- Data analysis of signals and feedback to the Safety Review Team (SRT) during the Signal Management meetings.
- Provide training and guidance and act as a mentor to less experienced departmental members.
- Initiate and participate in departmental or interdepartmental process improvement and training initiatives.
- Initiate and manage development of formats, templates and general guidelines for clinical documentation and workflow procedures.
- Assist in the development of departmental SOPs/WIs.
- Keep abreast of professional information and technology through workshops and conferences and ensure the appropriate transfer of that information to the department.
- Ensure systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOPs
- Adhere to agreed Key Performance Indicators (KPIs).
- Support the continuous development and improvement of the PV function while upholding Aspen core values.
- Maintain rigorous adherence to written procedures, e.g. SOPs/WIs.
- Adherence to Company Health & Safety procedures.
- Participate in training programmes.
- Any other duties as assigned by your Manager.
Requirements
EDUCATIONAL REQUIREMENTS
- Matric/ Grade 12
- B.Pharm (preferred); B.Sc. (Hons), B Sc. Pharmacology or equivalent scientific or clinical qualification
KNOWLEDGE & EXPERIENCE REQUIREMENTS
- 4 Years experience in pharmaceutical industry (clinical expertise)
- Strong knowledge of regulatory and medical authorities in South Africa
- Strong understanding of regulations, ICH guidelines, and GCP
- Extensive medical writing and expertise in submission
SOFT SKILLS REQUIREMENTS
- Results and performance driven – deliver results that meet or exceed expectations
- Integrity
- Work ethic
- Ability to meet deadlines
- Sense of urgency – responding to issues and opportunities in a timely manner
- Intellectual curiosity – willing to suggest and try new ideas
- Positive and pro-active approach to business tasks
- Excellent interpersonal and communication skills
- A solutions provider
- Manage evolving deadlines effectively with regular feedback and updates
- Enthusiasm and Drive to take ownership and drive process initiatives
- Service orientation
- Customer focused
- Logical thinking
- Information seeking
- Positive ‘can – do’ attitude
- Be able to work autonomously and have good problem-solving skills
- Able to cope with evolving deadlines effectively with regular feedback and updates
- Honest and trustworthy
- Respectful and highly personable
- Possess cultural awareness and sensitivity
- Flexibility & confidentiality are key requirements for this role.
COMPUTER SKILLS REQUIRED
- The applicant must be proficient in the various applications (Word, Excel and PowerPoint) within the Microsoft Office bundle.
Apply by
go to method of application »
KEY RESPONSIBILITIES
- General operational activities
- Execute daily tasks and according to the relevant standard operating procedures and work instructions.
- Adhere to agreed key performance indicators (KPIs).
- Support the continuous development and improvement of the Quality function while upholding the Aspen core values.
- Operate computer systems by capturing data, printing standard reports, etc.
- Perform reconciliations of data.
- Update and maintain systems, databases and trackers.
- Generate reports as per instruction.
- Collate data for ad hoc requests.
- Verify and interpret the accuracy of data and audit documentation.
- Obtain the necessary signatures for all relevant documentation.
- Maintain templates and lists
- Maintain accurate filing and retrieval of documentation.
- Manage projects as per guidance from the line manager and within agreed timeframes.
- Provide regular feedback on progress of projects and highlight any issues that require the line manager’s attention.
- Adhere to company policies and procedures.
- Participate in training programmes.
- Work with all members of staff to maintain and develop the positive progressive culture within Aspen.
- Maintain good relations and communications with all members of the team and respond politely and in a timely fashion to internal and external customers.
- Serve as an effective liaison and communicate with internal and external customers.
- Display a professional attitude when responding to customers and responding to enquiries in a timely manner
- Utilise systems, data bases and trackers to provide accurate information to internal and external customers on request.
- Adhere to deadlines/due dates.
- Escalate to the line manager all possible delays and critical issues.
- Any other duties as assigned by the line manager or head of department.
- Perform any other administrative tasks relating to your work as and when required.
- Manage and utilise resources effectively to keep processes cost effective.
Quality Management Systems
- Provide support for quality management system activities, including change controls, deviations, corrective and preventative actions (CAPAs), quality risk assessments, customer product quality complaints, annual product quality reviews, training, product recalls/withdrawals, self-inspections, internal/external audits of Pharmacare, regulatory intelligence and documentation such as standard operating procedures/work instructions and reports.
- Assist with the management of eQMS records in line with standard operating procedures.
- Initiate eQMS records timeously, close eQMS records timeously and ensure that eQMS records comply with guidelines, standard operating procedures, work instructions and policies.
- Follow up regularly on the progress of eQMS records with internal and external customers.
- Record customer product quality complaints in the eQMS, liaise with complainants to obtain the required information and complaint sample/s, respond to complainants and close customer product quality complaints timeously
- Arrange upliftment of the complaint sample from the Complainant.
- Courier the Complaint sample to the relevant Manufacturing site/Alliance Partner
- Arrange delivery of the replacement sample to complainant.
- Manage all complaint samples and send for destruction, post investigation, including additional replacement samples
- Perform a reconciliation of customer product quality complaints with internal and external customers.
- Compile, review and update controlled documents in the document management system including standard operating procedures, work instructions, forms, templates and attachments.
- Adhere to good documentation practices and data integrity principles.
- Prepare the self-inspection program, liaise with the relevant departments to schedule the self-inspection, participate in self-inspections, prepare the self-inspection reports and follow up on the progress of self-inspection findings, and corrective and preventative actions.
- Support the Quality Management Systems Pharmacist with annual product quality reviews, including the schedule, requesting and collating data, and compiling the report.
- Support the Quality Management Systems Pharmacist to compile and update the site master file and quality manual.
- Comply with Good Manufacturing Practice (GMP), Good Wholesaling Practice (GWP) and Good Distribution Practice (GDP) guidelines and regulations.
- Compile the quality systems management review report and quality trend report under the guidance of the Quality Management Systems Pharmacist or Quality Lead – Quality Management Systems.
- Participate in QMS monthly reviews
- Deliver internal training e.g. GxP training and SOP training.
- Facilitate the payment of annual licence retention fees.
- Maintain the training matrix, and training tracker.
- Identify training and development with the line manager.
- Implement training according to personal and team development plans.
- Coordinate upskilling and multi-skilling in line with staff development.
- Complete Change control, Change action, Deviation, Investigation, CAPA, Effectiveness check, Audit Finding records in accordance with the requirements of the QMS due dates
- Continuous Improvement
- Identify gaps within current processes, investigate the gaps and propose ways to close the gaps.
- Identify ways to streamline processes, resulting in greater efficiency and productivity.
- Generate accurate and easily retrievable information and statistics for the department.
Requirements
EDUCATIONAL REQUIREMENTS
- Matric / Grade 12
- Relevant Tertiary Qualification Preferred
KNOWLEDGE & EXPERIENCE REQUIREMENTS
- A minimum of 1-year administrative experience
- Experience in a Quality GxP-accredited pharmaceutical environment, preferably in a marketing authorisation holding entity, distributor, wholesaler or manufacturing facility
- Understanding of pharmaceutical quality matters, legislation, regulations, and guidelines.
- Having attended a quality or regulatory course would be advantageous.
- Computer skills in MS Office suite and Adobe required.
- Experience with electronic quality management systems, and document management systems
- Computer Literate – MS Office
SOFT SKILLS REQUIREMENTS
- Results oriented
- Systems thinking
- Focused
- Cooperation
- Proactive
- Responsibility & accountability
- Resilience
- Informal and formal communications skills
- Active listening skills
- Flexibility and tolerance for ambiguity
- Transition management
- Capacity for resistance to stress
- Perseverance and tenacity
- Understands the Aspen story
- Aspen knowledge
- Optimism
- Passion
- Curiosity/learning agility
- Self-awareness
- High standards
- Effective planning and organisation skills
- Customer focused – understands the needs and priorities of the customer
- Accuracy and attention to detail
- Manage evolving deadlines effectively with regular feedback, and updates
- Integrity
- Work ethic
- Ability to meet deadlines
- The ability to communicate effectively (written and verbal) is essential
- Sense of urgency
- Information seeking
- Service orientation
- Time management
- Strong administrative skills
- Ability to multitask and strong proven follow-up skills is a requirement.
- Planning, organizing and communication skills.
- Excellent communication skills, including verbal and written proficiency in the English language
COMPUTER SKILLS REQUIRED
- The applicant must be proficient in the various applications (Word, Excel and PowerPoint) within the Microsoft Office bundle.
go to method of application »
Requirements
JOB REQUIREMENTS:
- Minimum Education Qualification – Matric/Grade 12, with Mathematics
- A Diploma in Stores Management would be advantageous
- 3 years’ experience in a manufacturing/engineering/ stores environment preferably in the Chemical, food or Pharmaceutical Industry
- A valid forklift driver’s license is preferred
- Must be computer literate, MS Windows, i.e. Word, Excel, Outlook, etc.
- Must possess good administrative skills
- Ability to plan and work in an orderly, logical, and systematic manner
BASIC JOB FUNCTIONS (Brief Summary):
- Ensure that all materials are issued from or received in the engineering store.
- Perform forklift driver duties as and when required.
- Ensure that all EH&S rules are abided by in all storage areas as well as when moving items around the site.
- Accurately capture all data onto SAP and complete all required SAP transactions.
- Ensure that stock/ ordered items delivered are checked and correctly booked into SAP and correctly stored.
- Ensure that stock is accurately picked and issued.
- Ensure that stock counts are accurately done within the required timelines.
- Ensure that the issuing, receipt, storage and maintenance checks of applicable engineering tools and equipment is completed correctly.
- Ensure that the storage and stock counts for all Production Equipment Storage in the C1 Store and containers is completed correctly.
- Ensure that the Engineering Store, storage containers and surrounds and C1 Store are always kept clean and tidy.
- Assist Engineering project Staff with the storage, issuing and stock counts of project stock where required.
PERSONAL ATTRIBUTES (Brief Summary):
- Able to work in a team as well as independently when required.
- High attention to detail and accuracy.
- Good communication (written and verbal) as well as good data-capturing skills.
- Good interpersonal skills and ability to maintain good internal customer/supplier relations.
- Able to work extended hours at short notice if required
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Requirements
JOB REQUIREMENTS:
- Grade 10 and/or equivalent.
- Formal Trade qualification/ verification as bricklayer/ plasterer or similar would be preferred.
- A minimum of 3 - 5 years’ experience in general building or building maintenance.
- Ability to do general bricklaying and construction tasks including tiling, epoxy flooring, dry wall installation and painting,
- Basic plumbing ability and experience in cleanroom panelling installation would be advantageous.
BASIC JOB FUNCTIONS (Brief Summary):
- Building new structures as per drawings and instructions.
- Conducting building maintenance and renovation tasks as required.
- Generation of BOQ for assigned work.
- Supervising and assisting external civil works contractors and/or other FCC Engineering staff as required.
- Supporting Projects and Engineering work in general maintenance tasks and other project work.
- Assessing assigned tasks in order to complete the task in the required timeframes and standard required to facilitate current good manufacturing practices (cGMP).
- Operation and general maintenance of assigned tools and equipment.
- Adherence to safe working practices and general health and safety regulations.
PERSONAL ATTRIBUTES (Brief Summary):
- Able to work in a team as well as independently when required.
- High attention to detail and accuracy.
- Must have the ability to plan tasks and have good administration skills.
- Able to work extended hours at short notice if required.
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OBJECTIVE OF ROLE
- Manage all internal and external pricing and re-imbursement activities to enable Aspen’s product portfolio in line with business strategy
KEY RESPONSIBILITIES
- Ensuring a standardized Aspen pricing management process is in place that enables commercial decision making and pricing decision implementation.
- Implementation of pricing submissions effectively and efficiently through an engagement process with the National Department of Health for the submission of Single Exit Price revisions.
- Preparation of all materials for pricing reviews, identification of pricing issues and project management all identified issues to resolution.
- Development of product pricing and reimbursement scorecards to enable commercial team decision making and communication to commercial teams.
- Development of a product portfolio reimbursement process via a structured database of access and re-imbursement information affecting Aspen products.
- Communication of the structured product reimbursement criteria to the sales teams and brand managers, to enable the commercial team’s commercial activities.
Requirements
EDUCATIONAL REQUIREMENTS
- Bachelor’s degree is a minimum requirement (in health, science, business or management)
KNOWLEDGE & EXPERIENCE REQUIREMENTS
- 5 years plus experience in the Commercial Pharma (Finance/Marketing/Sales) environment is essential, including experience in pharmaceutical pricing and reimbursement,
- Must have the demonstrated ability to build relationships within complex organizations and contracts,
- Able to project manage strategic and operational execution within pricing and reimbursement roles,
- A sound understanding of the pharmaceutical market dynamics is required, with experience in pricing, procurement and contracting,
- Able to develop robust forecast models with structured underlying assumptions,
- Experience in Financial planning, Risk Management and contracting mechanisms with a sound financial understanding of P&L development in the pharmaceutical industry setting,
- Knowledge of regulatory processes and legal documents, e.g. contracts/agreements, patents and trademark searches,
- Ability to engage internal and external pricing and reimbursement stakeholders to manage the Aspen pricing and reimbursement process.
- Must have a comprehensive understanding of the medicines and related substances Act as it relates to the Single Exit Price, Medical Schemes Act and its consequences on Aspen’s product portfolio and product pricing decisions and potential consequences.
- Proficient knowledge of the pricing and reimbursement landscape in South Africa, with a thorough understanding of commercial pharmaceutical strategies and tactics to ensure commercial ambitions are realized
SOFT SKILLS REQUIREMENTS
- Strong analytical and negotiation skills
- Exemplary Communication Skills
- Skillful presenter of scientific and business information to executive level audiences
- Demonstrated complex transversal project management skills
- Sound time management skills and deadline driven by a sense of urgency.
- Ability to work independently, under pressure and use initiative.
- Forward thinking, proactive, problem-solving and results oriented
- Strong networking capabilities and the ability to work cross-functionally
- Customer Centricity (Internal and external)
COMPUTER SKILLS REQUIRED
- Proficient in Microsoft Office (Excel, Word, PowerPoint and Outlook).
Method of Application
Use the link(s) below to apply on company website.
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