Fresh Vacancies at Aspen Pharma Group

Description

Fine Chemicals Corporation requires the services of a highly competent individual to fill the position of Validation Technician. To qualify for this position candidates must fulfill the following requirements

JOB REQUIREMENTS:

• Matric/Grade 12 with Mathematics and Science
• Technical / Engineering qualification which has been completed or studying towards the completion of your qualification (part-time)
• At least 1-3 years’ experience in a cGMP environment preferably in the pharma industry
• Technical experience would be an advantage, in chemical and mechanical processing equipment /systems

BASIC JOB FUNCTIONS:

• To provide technical and administrative support for the validation section responsible for equipment qualification
• Report to the senior validation team
• Drafting, executing, and reporting on equipment qualifications for new and existing equipment, systems, and utilities used in the manufacturing of intermediate and finished active pharmaceutical ingredients (API)
  • Maintain administration required for qualification documentation as per relevant SOPs
  • Liaise with various departments, suppliers, and external contractors regarding validation qualifications
  • Witness/execute qualification trials/tests/activities (IQ/OQ/FAT/SAT etc.)
• Preparation of validation qualification documentation for audits, internal and external
• Assist with closure of equipment change controls related to projects worked on
• Maintain engineering/validation databases.
• Comply with GMP requirements as outlined by Company SOP's and written instructions in all tasks and activities.

PERSONAL ATTRIBUTES (Brief Summary):                                                              

• Excellent verbal & written communication skills
• Must have the ability to work within a challenging environment
• Must be numerate and show attention to accuracy
• Good organisational skills, hands-on and pro-active
• Good intrapersonal and interpersonal skills
• Proficient in Microsoft Office
• Ability to work at heights and confined spaces
• Proficient report writing skills 

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Job Overview

• Review and approve batch documentation in line with SOP and quality standards
• Perform lab quality review in line with SOP
• Provide services according to Production plan
• Related administrative tasks

Responsibilities 

Planning and Operational Support

• Oversees work and/ or serve as a lead technical expert
• Optimise and facilitate implementation of current processes
• Identify gaps in current policies and procedures
• Propose changes or improvements to processes, tools and techniques
• Provide information for reports, as required by superior
• Provide analytical support in the absence of the TL
• Provide support during regulatory audits.

Lab Quality Review 

• Perform LQRs according to Production plan
• Review and approve lab records to ensure pharmaceutical analysis has been carried out as per MOA; direct queries to laboratory
• Electronic approval of analytical results on relevant software. e.g. Empower
• Evaluate and interpret chromatography data to ensure accuracy of results.
• Review and approve batch documentation compliance with SOPs and quality standards
• Correct errors in batch documentation, in line with GMP standards, SOPs, and product specifications
• Record all OOS investigations and conclusions, and report to management
• Provide advise to analysts during laboratory investigations.
• Provide input into SOPs
• Ensure that products are produced, tested and stored according to the required SOP’s and documentation
• Ensure adherence by Analyst/ Tester before release

Reporting and Record-Keeping

• Document and store data according to SOPs and regulation
• Consolidate information for reports on weekly/ monthly basis
• Analyse consolidated data and provide recommendations
• Compile detailed and standardised reports and consolidated documents
• Initiate deviations once picked up during reviewing.

Requirements

Skills Required

Background/experience

• National Diploma in Analytical Chemistry with 6+ years’ experience
• Laboratory experience

Specific job skills

• Understanding of pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives
• Strong technical knowledge and be competent in the use of all laboratory equipment, software and techniques.

Competencies

• Interrogating Information
• Following Procedures
• Maintaining Accuracy
• Customer Awareness

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OBJECTIVES: 

• 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 the current product portfolio in the South Africa and South African Development Community (SADC) region, by ensuring successful Marketing Authorisation and variation approval from the SAHPRA and Regulatory Authorities of the SADC member states within the committed timeframe.
• The role undertakes responsibility for compliance with the regulatory / pharmacovigilance requirements.
• New Product Launch Pipeline and the existing product portfolio in the region, through successfully completing assigned activities according to the South African and SADC Regulatory plan.
• To establish a central point of contact for all medical writing projects for the Regulatory Affairs South Africa entity of the Aspen Group by liaising with other Pharmacare departments as the need arises.
• To undertake all research, creation and editing of all documents to comply with safety and clinical updates according to the Pharmacare Company Core Datasheet (CCDS).

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, 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 the 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 the 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 the development of documents.
• Prepare country-specific packs for submission of safety variations within ZA.
• Assist in the assessment of clinical and nonclinical documentation with   regards to its suitability for supporting new marketing authorisation applications (MAA) or new indications.

SAFETY

• Aggregate reporting:
  • Preparation of aggregate safety reports including but not limited to PSURs, PBRERs and Addendum Safety Reports.
• Risk Management System:
  • 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.
• Signal Management:
  • 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.

TRAINING

• 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 the 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.

GENERAL

• Ensure systems and procedures are in place following 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's 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. 

EDUCATION & EXPERIENCE

• Matric/ Grade 12
• B.Pharm (preferred); B.Sc. (Hons) or equivalent scientific or clinical qualification
• 4yrs experience in pharmaceutical industry (clinical expertise)

KNOWLEDGE

• 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.

SKILLS AND ATTRIBUTES

• 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.

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OBJECTIVES: 

• 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 South Africa and South African Development Community (SADC) region, by ensuring successful Marketing Authorisation and variation approval from the SAHPRA and Regulatory Authorities of the SADC member states within the committed timeframe. 
• The role undertakes responsibility for compliance with the Regulatory / Pharmacovigilance 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 South African and SADC Regulatory plan.
• To provide support to the Pharmacovigilance (PV) function of the SA Regulatory Affairs department in the receipt, assessment, processing and reporting of Individual Case Safety reports (ICSRs) in accordance with PV procedures and PV legislation by ensuring compliance is met with Regulatory bodies, affiliates and partners within the stipulated timelines.

KEY RESPONSIBILITIES

PHARMACOVIGILANCE SUPPORT

• ICSRs (Individual Case Safety Reports)
  • Performing assessment of adverse event case reports.
  • Act as case owner for assigned ICSRs to ensure accurate completion of data entry (DE), data review (DR) and regulatory reporting (RR), in line with current SOPs.
  • The PVO acts as a product owner for products under the remit of Pharmacare, supporting the PV Scientists with literature management and aggregate report preparation.
  • Maintain a high standard of case quality.
  • The PVO is responsible for providing a root cause analysis for any late reporting submissions.
  • Managing and prioritising individual workload while maintaining good documentation practices (GDP).
  • Highlighting any safety-related issues to the attention of the management team.
  • Perform pharmacovigilance checks/evaluations of the Quality Assurance database (Trackwise Digital).
• Reconciliation
  • Reconciliation of all adverse event reports received by PV from internal stakeholders (QA/MIC and ACC).
  • Reconciliation of all adverse event reports received from PV service providers, affiliates, distributors and license partners monthly, quarterly or bi-annually as described in the Safety Data Exchange Agreement (SDEA).
• Quality Systems Management
  • Support preparation of SOPs, WIs, and product safety reviews.
  • Raising compliance cards for late cases reported to Pharmacare by service providers, affiliates, distributors and license partners.
  • Ensure all allocated CAPAs, Deviations and Actions are closed on time on Trackwise Digital.
• Aggregate Reporting and Regulatory Intelligence
  • Keep abreast of changes to PV Legislation and ensure Regulatory Intel is monitored for ZA and SADC territories.
• Basic PV training for all Aspen employees
  • Contribute to the development of PV training.
  • Pharmacovigilance training of all Aspen employees and distributors/service providers and documentation thereof.
• Literature reviews
  • Regulatory review of key Medical Journals for any adverse drug reaction reports with Aspen Pharmacare products/medicines.
• Understand SDEA obligations in order to ensure all aspects under agreements are duly executed.
  • Facilitate SDEA training (to employees as well as 3rd parties).
• Signal management
  • Highlighting any safety related issues to the attention of the management team.
  • Co-ordinate Safety Review meetings (monthly).
  • Reviewing of Regulatory websites for any potential signals.
• All other ad hoc PV activity duties as required by the business needs.
• Adhere to agreed Key Performance Indicators (KPIs).
• Support the continuous development and improvement of the PV function while upholding Aspen core values.
• Receipt, evaluation and reporting of individual case safety reports in accordance with international (export territories) and local regulatory requirements and contractual partner obligations.
• Provide support to Global PV. 

CUSTOMER SERVICE

• All queries are followed up and strictly within the policy framework i.e. 48 Hours turn-around time.
• A professional attitude is displayed when responding to a customer’s needs.
• Methods for improving customer services are proposed.
• Internal and external customers are kept updated, under supervision, as to the progress of their queries.
• Liaise on a daily basis with RA customers, i.e. SAHPRA, Marketing, Manufacturing sites, Quality-related departments, Public Health, Exports, outsourcing, and relevant licensors and distributors.

FINANCIAL

• Identification of project challenges to departmental line management and the financial impact thereof.

 GENERAL

• Ensure systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOPsAdhere to agreed Key Performance Indicators (KPIs)
• Support the continuous development and improvement of the PV function while upholding Aspen's core values.
• Effective management and utilisation of resources to keep processes cost-effective.
• Collating data for ad hoc requests.
• Adherence to Company Health & Safety procedures.
• Participate in training programmes.
• Any other duties as assigned by your Manager.

EDUCATION & EXPERIENCE

• Bachelors or Post Graduate degree in science, pharmacy or medicine, or Post Basic Pharmacist Assistant.
• PV experience (2 years).
• Experience in post-marketing reporting of AEs.
• Quality Assurance experience (1 year).
• GCP training advantageous 

KNOWLEDGE

• Knowledge of relevant information sources including: printed publications, unpublished sources, databases, websites, social media sites and external bodies.
• Effective understanding and use of the principles of information capture, storage, searching and retrieval.
• Effective use of appropriate IT systems and programs.
• Understanding of relevant legal and related issues on copyright, codes of Practice, Data Protection legislation, regulations and guidelines.

SKILLS AND ATTRIBUTES

• Business process analysis.
• Report writing.
• Information gathering and monitoring.
• Projects (advantage).
• Ability to communicate information effectively and clearly in written form and orally, and at levels appropriate to the needs of different internal and external customers.
• Integrity.
• Work ethic.
• Ability to meet deadlines.
• Positive ‘can – do attitude’.
• Work autonomously and have good problem-solving skills.
• Able to cope with evolving deadlines effectively with regular feedback and updates.
• Honest and trustworthy.

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Job Overview

• Lead routine packaging technology work, including creating and maintaining printed component artworks, specifications and packaging bill of materials
• Co-ordinate the phasing out of old artwork and the phasing in of the new artwork without compromising continuity of supply

Responsibilities:

Specifications

• Draft primary and secondary packaging specifications
• Conduct specification maintenance and provide quality control support

Packaging Bill of Materials

• Ensure Prelim Packaging Bill of Material Specifications are generated in compliance with all internal and external stakeholders
• Set up and maintain Packaging Bill of Material

Artwork Process

• Coordinate communication between Artwork Originators, Design Studios, Print Suppliers and International and Local manufacturers
• Proofread artwork for accuracy 
• Set up artwork with suppliers and update Artwork system (PULSE) with required feedback
• Maintain technical drawings
• Conduct document compliance and process compliance checks

Good Manufacturing Practice and Reporting

• Complete all records and reports timeously and accurately as described in the relevant SOP’s, protocols and associated documentation
• Comply with GMP / GLP requirements as outlined by company SOP’s and written instructions in all tasks and activities

Technical Expertise

• Identify gaps in current policies, procedures and legislation
• Propose changes or improvements to management on processes, tools, techniques, and products

Asset/ Resource coordination

• Provide input into required changes in resources to enable achievement of team and/ or own objectives 

Artwork Implementation 

• Calculate run in and out dates of artwork and allocate priorities
• Co-ordinate activities to ensure no impact on supply
• Calculate  potential write off value and obtain approval
• Update PULSE with the details of last order in old artwork & first order in new artwork
• Change owner of the change control to implement new artwork and discontinue the old pack material item masters & master docs.
• Co-ordinate all activities to implement and  discontinue a finished product in our system

Requirements

Skills Required

Background/experience

• 1-3 years’ experience in a Pharmaceutical Packaging Development / Packing environment
• Minimum of Diploma in Packaging Technology / Graphic Design or a Qualification in Inventory Management

Specific job skills

• Computer literate with specific Intermediate Excel skills.
• Packaging converting processes and materials knowledge.
• Desktop Publishing

Competencies

• Taking Action
• Meeting Deadlines
• Finalizing Outputs
• Following Procedures
• Working in Teams
• Customer Awareness

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OBJECTIVE: 

• The SED graduate will be employed on a graduate programme for 12 months to advance their skills with SED activities as the person chosen will have this as their primary interest.
• The graduate will go through a robust training process whilst to a larger extent being exposed to ensuring that meaningful impactful contributions to the communities are realized through which we operate. They will be working under the guidance of an experienced CSI Manager.
• This person would be exposed to the various departments within the CSI team in order to gain insight on the collaborative work required within the division. The second level of exposure would be to the Business in stages to align with the business support aspect of this role and understand where the role fits within the organisation.

As a graduate you will be exposed to the following:

• Process payments for SED (Social Economic Development) initiatives and programs
• Liaise with the finance department to ensure timely payment of invoices and tracking of expenses
• Maintain accurate and up-to-date records of all SED activities and initiatives
• Provide administrative support to the SED team as needed, including preparing reports, managing files, and organizing events
• Schedule and coordinate meetings and events related to SED activities
• Assist in drafting and proofreading documents, including reports and presentations
• Collaborate with other departments within the organization to ensure effective coordination of SED initiatives
  Perform other administrative tasks as needed to support the SED team.
• Assistance on work whilst learning.
• Accompanying meetings to generate minutes and distribution of actionable points to relevant stakeholders etc.
• Generating simple reports

Requirements

QUALIFICATIONS AND EXPERIENCE

• Matric/ Grade 12
• Must have degree/Diploma in Communications/Public Relations OR Business/Finance 

KNOWLEDGE AND SKILLS

• Interest in social responsibility, community development, and/or philanthropy
• Proficiency in Microsoft Office programs, such as Excel and PowerPoint
• Excellent skills in effective communication verbally and in writing with diverse groups including key business associates (executive level) and technical associates.
• The ability to interact with colleagues.
• Critical thinking, analytical and problem-solving skills.
• Strong organizational and administrative skills
• Excellent attention to detail and ability to apply learnings independently.
• Ability to manage multiple tasks at one time
• Must have a sense of urgency for deadline-driven tasks
• Ability to work effectively in a team environment