Current Openings at Aspen Pharma Group

Description
Overview

• Manage and support production processes and outputs
• Long term production and shift planning
• Problem identification and solution engineering
• Manage and guide production staff through team leaders
• Performance management of direct reports, monitoring of performance management within department
• Reviewing and approving production instructions, validation and qualification of manufacturing equipment and tools

Responsibilities

• Planning and Unit Management
•  Provide technical and operational input into processes, procedures and policies
• Coordinate the communication, management, and implementation of strategic plans and monitor implementation
•  Build and maintain relationships with internal and external stakeholders
•  Develop, implement, and monitor Focus Factory operating budgets
• Ensure availability and optimal allocation of resources within unit
• Perform HR functions for optimal management of unit
• Empower subordinates through training, information sharing, coaching, feedback, appraisals, and delegation, to ensure the development of people, teams, and organisational capabilities
• Attend production, quality and safety meetings
• Production Planning and Process Management
• Ensure operational excellence with regards to safety, quality, and productivity of the Focus Factory, and its ability to deliver high levels of service to internal and external customers
• Manage people, materials, equipment, business and manufacturing processes to deliver Factory performance objectives, as measured by factory KPI's
• Ensure compliance with policies/procedures for shift rotation, vacation scheduling, and training to meet business needs including peak production periods
• Manage the development and implementation of daily production schedule to ensure high levels of OTIF to internal and external customers
• Ensure effective implementation of new technology and products
• Implement TPM and other continuous improvement programs
• Develop and implement CAPEX budgets
• Ensure integrity of business processes related to finished goods inventory replenishment, and new product introductions
• Governance, Risk & Compliance
• Ensure adherence and compliance to regulatory requirements
• Ensure that appropriate validations are completed as per validation requirements and schedule
• Initiate and set targets, and review GMP, quality and training needs

Requirements

Skills required

Background/experience

• Minimum of Bachelor’s degree preferred, ideally in Pharmacy/ Engineering/ Chemistry with 10 years’ related experience
• Pharmaceutical manufacturing experience
• Project Management experience

Specific job skills

• Strong working knowledge of Pharmaceutical manufacturing
• Problem solving and solution engineering
• Pharmaceutical standards and compliance requirements
• Coaching, leadership and mentoring
• Ability to interpret and implement policies, processes and objectives

Competencies

• Offering Insights
• Making Decisions
• Managing Performance
• Customer Awareness
• Developing Others

go to method of application »

Description
Overview 

• Monitor manufacturing compliance to GMP and statutory requirements
• Monitor adherence to guidelines, procedures and document controls
• Deliver expected value stream targets as per business requirements
• Facility GMP compliance
• Team and process development

Responsibilities

• Staff development
• Train new Pharmacists and PMAs on SOPs in transition period
• Ensure pharmaceutical and supervisory team training is compliant
• Oversee staff professional development to ensure team value add is realized
• Facilitate training sessions as required
• Mentorship and guidance to pharmaceutical teams
• Product release management
• Facilitate end to end product release process withing production department
• Deviation management and adherence to daily, weekly targets
• Raise deviations, complete forms and investigations as required and implement corrective action
• Facilitate incident review process
• Maintain and update records and systems as required
• Retrieve supporting documentation and records to facilitate and support query resolution
• Ensure deviation owner allocation and re-allocation in accordance to priorities
• Ensure CAPA actions are implemented (deviations, CAPAs, Change controls)
• Process and system improvements
• Continuously review process impacting manufacturing and release to identify and implement optimization measures to improve efficiency and effectiveness
• Manage, review and approve change control programs and deviations/ concessions comply to standards and specifications
• Optimise processes and identify gaps in policies/ procedures
• Drive CAPA investigations in area of focus
• Implement and maintain KPIs and trackers supporting business objectives
• Planning
• Plan and prioritise own and team daily, weekly and monthly activities
• Determine, request and use resources/ assets optimally
• Align activities with business and customer product release priorities
• Stakeholder management
• Key interface between production and support departments with main interface being with the QA department
• Customer interface as needed to share information, feedback on open items,  
• retrieve guidance and facilitate priorities
• GMP Compliance
• Facilitate and support audit management
• Enforce and control area compliance (personnel, documentation, process, product)
• Ensure production process adherence to standards and specifications
• Enable teams and process to achieve documentation and deviation right first time targets

Requirements
Requirements

Background/experience

• BPharm Degree
• 1-3 years’ related work experience
• Pharmaceutical manufacturing experience

Specific job skills

• Comprehensive knowledge of pharmaceutical manufacturing, standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives

Competencies

• Leadership
• Managing complex task and integration of multiple variables
• Interrogating information
• Meeting deadlines
• Finalising output
• Taking action

go to method of application »

Description
Requirements:

• Senior National Certificate /Grade 12
• Degree or National Diploma in Industrial Engineering
• South African Citizen
• Aspen fully subscribes to the principles of Employment Equity and will make decisions in line with this ethos.
• Aspen reserves the right to not make an appointment.
• Incomplete applications will not be considered.
• Candidates may be required to undergo assessments.
• Please note that if you have not heard from the HR department within 30 days of this advert closing, your application has unfortunately been unsuccessful.
• Aspen subscribes to the principles of Employment Equity and will make decisions in line with this ethos.
• This one-year internship programme at our SA Operations manufacturing site (Gqeberha) will provide candidates with an opportunity to gain workplace experience, knowledge and skills related to the pharmaceutical industry.
• Please submit your application via Direct Hire online platform, where the following documents are required to be attached. Please scan all the documents as one document and upload it to the Direct Hire CV section:
• Curriculum Vitae
• Certified copy of your ID
• Certified copy of your National Senior Certificate
• Latest University certified/stamped academic transcript.

go to method of application »

Description
Overview

• Operate equipment in the manufacturing and packing of products
• Prepare, clean and inspect work areas and equipment
• Troubleshoot machines and raise maintenance issues
• Carry out required training and administrative tasks

Responsibilities

• Operational Support
• Identify gaps in current policies and procedures
• Optimise and facilitate implementation of processes
• Operate equipment as per standards and expected efficiency, and ensure compliance to GMP and SHE standards
• Inspections & Verifications
• Perform pre-production checks such as environmental, scale and equipment pre-checks as per BMR, SOP and product specifications
• Verify scale and measuring equipment performance
• Production Preparation
• Ensure availability of materials and equipment for manufacturing
• Perform Type-A and Type B changeovers; Clean and prepare the area and equipment before and after processing
• Prepare solutions for production activities as per SOP
• Production Processing
• Clear and feed the manufacturing line
• End of line packing and inspections
• Perform central lining review to establish optimal production settings
• Routine Support Tasks
• Clean area and equipment before and after processing of materials
• Perform equipment pre-checks and facilitate transfer of equipment
• Sort defected product and dispose of according to procedures
• Provide information to assist with campaign preparation
• Train new Assistants and Operators and transfer of skills
• Operate manufacturing and packaging lines as per requirements
• Resolve minor - and assist with major breakdowns/ maintenance
• Perform change overs, settings and minor maintenance as per autonomous maintenance standards
• Troubleshooting
• Conduct root cause problem analysis on machines
• Raise maintenance issues with management for resolution
• Perform adjustments and preventative maintenance on machines
• Reporting & Record Keeping
• Complete batch record labels and OEE sheets
• Perform half-hourly inspections of production area(s)
• Record manufacturing/ machine down time
• Attend shift meetings
• Perform IPQC or quality inspections per responsible areas
• Provide information for reports; consolidate standard documents
• Maintain and update records and systems as required

Requirements
Skills Required

Background/experience

• National Certification (N3) with 0-2 years’ related experience
• Manufacturing experience

Specific job skills

• Basic technical knowledge of Pharmaceutical production processes, procedures, systems and equipment.
• Basic understanding of Pharmaceutical standards and compliance requirements

Competencies

• Finalising outputs
• Following procedures
• Taking action
• Information gathering

go to method of application »

Description
Overview

• Perform microbiological tests on raw materials, water, cleaning and environmental samples, in-process and final products to ensure quality and compliance
• Review compliance of documentation according to pharmaceutical standards

Responsibilities

• Planning and Operational Support
• Optimise and facilitate implementation of current processes
• Identify gaps in current policies and procedures
• Propose changes or improvements to processes, tools and techniques
• Microbiologist Testing
• Perform microbiological tests on raw materials, in-process and final products to ensure quality and compliance with GMP standards
• Test water according to SOPs and testing schedule
• Notify Production of source of any contamination timeously
• Develop and implement plans to control level and source of contamination
• Environmental Management
• Perform sampling and testing of external environment, according to SOPs and sampling plan/ schedule
• Quality Control
• Report OOS results and deviations immediately
• Manage frequency of testing and sampling to maintain a quality process
• Maintain good housekeeping
• Manage and coordinate the use, maintenance and calibration of testing equipment according to SOPs
• Ensure continuous compliance of laboratory with GMP standards
• 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

Requirements
Skills Required

Background/experience

• National Diploma in Microbiology with 6+ years experience
• Microbiological laboratory experienc

Specific job skills

• Advanced knowledge of microbiological testing methods
• Understanding of pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives

Competencies

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

go to method of application »

OBJECTIVE:

• 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 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:

• 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.
• Management and prioritisation of 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 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).
• Support preparation of SOPs, WIs, and product safety reviews.
• Raising of 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.
• Keep abreast of changes to PV Legislation and ensure Regulatory Intel is monitored for ZA and SADC territories.
• Contribute to the development of PV training.
• Pharmacovigilance training of all Aspen employees and distributors/service providers and documentation thereof.
• Regulatory review of key Medical Journals for any adverse drug reaction reports with Aspen Pharmacare products/medicines.
• Facilitate SDEA training (to employees as well as 3rd parties).
• Coordinate Safety Review meetings (monthly).
• Reviewing of Regulatory websites for any potential signals.
• Aggregate Reporting and Regulatory Intelligence.
• Basic PV training for all Aspen employees.
• Literature reviews
• Understand SDEA obligations to ensure all aspects under agreements are duly executed.
• 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's 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 Group PV.
• 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.
• Identification of project challenges to departmental line management and the financial impact thereof.
• Ensure systems and procedures are in place in accordance with the RA QMS and that these are maintained according to the relevant SOPs.
• 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 the training programme.s
• Any other duties as assigned by your Manager.

Requirements
EDUCATION & EXPERIENCE:

• Bachelors or Post Graduate degree in science, pharmacy or medicine, or Post Basic Pharmacist Assistant
• PV experience (1 -2 years);
• experience in post-marketing reporting of AEs;
• Quality Assurance experience (1 year);
• GCP training is 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.
• Ability to communicate information effectively and clearly in written form 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.
• Respectful and highly personable.
• Possess cultural awareness and sensitivity.
• Flexible and confidential.
• A positive and proactive approach to business tasks.
• Enthusiasm and drive to take ownership and drive process initiatives. 

go to method of application »

Description

• Fine Chemicals Corporation requires the services of a highly competent PMO Manager. To be considered for this position, candidates must fulfill the following requirements:

JOB REQUIREMENTS:

• Degree / B-Tech in Mechanical Engineering
• Project Management Professional (PMP) or similar qualification/ certification
• Minimum 10 years’ Project Engineering and Project Management experience, preferably within the Pharmaceutical, Chemical, or FMCG fields.
• Proven experience in leading engineering teams and managing large-scale projects

BASIC JOB FUNCTIONS (Brief Summary):

• Develop procedures and policies for the establishment of a Project Management Office (PMO) at FCC.
• Manage the day-to-day function of the PMO.
• Develop, plan and co-ordinate all projects at FCC, this includes engineering, product and IT projects.
• To control project expenditure within capex approvals and ensure project deliveries as per agreed schedules.
• Ensuring adherence to project management and engineering standards and policies.
• Generate and review project proposals.
• Provide detailed input into annual and long-term Capex budgets
• Ensure sustained adherence to cGMPs and OHSE regulations during the design and implementation of project activities.
• Provide detailed reporting on project activities to site leadership.
• Initiate and implement maintenance and continuous improvement projects.

PERSONAL ATTRIBUTES:

• Strong understanding of engineering principles and the ability to grasp complex project details.
• Ability to lead and mentor engineering and project teams effectively.
• Excellent written and verbal communication abilities.
• Strong attention to detail and ability to manage multiple projects simultaneously.
• Ability to align engineering projects with organizational goals and strategies.
• Ability to work independently and on own initiative with a high level of self-motivation.
• Has a high work capacity and ability to prioritise and multi-task.  
   

go to method of application »

OBJECTIVE OF ROLE

• Responsible for the promotion of products within a certain geographical area to Pharmacy clinics, Clinic nurses, pharmacists, and Specialists (Gynecologists and Pediatricians). Responsible for building and strengthening relationships with Key External Medical Experts. 

KEY RESPONSIBILITIES 

• Commercial Excellence
• Achieve sales targets and expand market share within the assigned territory.
• Schedule and attend appointments with healthcare professionals (doctors, nurses, pharmacists) to promote product adoption and meet sales goals.
• Utilize analytical skills to interpret both internal and external data sources.
• Possess in-depth product knowledge and effectively use detailed materials to engage in meaningful discussions with customers.
• Develop and maintain strong relationships with key customers to build trust and secure commitments.
• Collaborate efficiently with various stakeholders across the organization.
• Detail healthcare professionals (pharmacists, nurses, specialists) in the private hospital sector.
• Foster and grow relationships with thought leaders by engaging in peer-level discussions about the product portfolio.
• Provide continuous support to healthcare professionals by gathering feedback on Aspen Vaccines products to ensure their effective and safe use.
• Manage and oversee the product portfolio within the territory, including business planning, territory analysis, and achieving customer call volume and coverage targets.
• Offer ongoing customer support to enhance product and disease knowledge through training sessions, CPD meetings, journal clubs, and webinars.
• Resolve customer complaints by investigating problems; developing solutions; preparing reports; making recommendations to management.
• Communicate and report on drug adverse reactions within 24 hours and ensure that all product complaints are resolved within the respective timelines.
• Adherence to all CCCO expectations in customer interaction and activities 
• Adherence to business rules i.e., call rates standards, call logging adherence, and ensure submission of monthly and weekly planners and reports.
• Value Creation
• Monitor and analyze data and market conditions to identify competitive advantage and product usage to improve sales performance
• Pursue continuous learning and professional development and stay up to date with the latest industry trends,
• Plan and organize and arrange training to HCPs
• Promote products ethically and within compliance based on company’s sales process and approved marketing strategy 
• Compliance
• Adherence to all compliance expectations in customer interaction and activities

Requirements
EDUCATIONAL REQUIREMENTS

• Matric / Grade 12
• A tertiary qualification is required, ideally in the life sciences. 

KNOWLEDGE & EXPERIENCE REQUIREMENTS

• A minimum of 3 years’ experience as a Pharmaceutical Detail Sales Representative.
• Existing relationships with target key customers in Johannesburg (Northern & Southern Suburbs, the West & East Rand and Mpumalanga) would be an advantage.
• Understanding of budgeting, forecasting processes and financial calculations (gross margins, mark-ups etc.), is preferred
• Experience implementing a marketing strategy is ideal

SOFT SKILLS REQUIREMENTS

• Territory Management
• Presentation skills
• Communication skills; both written and verbal
• Negotiating skills
• Interpersonal skills with the ability to work independently and as part of a team.
• Effective planning, prioritization, organizing and coordinating.
• Ability to think creatively and out of the box, to effectively solve problems
• Results driven and self-directed
• Able to skillfully analyze data to gain insight and plan of action
• Ability to work under pressure and manage time productively

go to method of application »

Description
Overview

• Lead and support Continuous Improvement (CI) and Operational Excellence initiatives. 

Responsibilities

• Process Alignement
• Develop and publish deadlines, targets and measures, and communicate departmental targets and outputs.
• Plan, prioritise and review technical plans for the improvement of production and facility equipment.
• Facilitate meetings to analyse process input variables and interpret impact upon customers’ needs.
• Develop and update process documentation and training materials to support new or modified processes.
• Evaluate, justify and qualify changes in existing processes or processes equipment.
• Review production information to understand methods and activities in manufacturing and services. This includes, but is not limited to, production schedules, process flows and engineering specs
• Project management and coordination
• Manage CI, site loss elimination and lean improvement projects to provide greater value, implementing relevant tools and processes.
• Provide technical support to SCM, writing technical specifications
• Continuous improvement (CI)
• Focus on measurable quality, service and cost improvements.
• Work with departments to develop training material pertaining to processes, raw materials, equipment operations and operator safety.
• Elicit production and operational issues from operators.
• Troubleshoot, diagnose and resolve equipment, manufacturing process and facilities issues.
• Standardise/ modify existing manufacturing processes to increase robustness, reliability, and compliance and reduce production costs, lead times, inventories, downtime and waste.
• Implement and monitor corrective action and innovative action within set target dates.
• Design control systems to minimize and resolve production issues and project costs.
• Reporting
• Prepare technical reports for all work performed.
• Present process related data and communicates issues related to projects for review and discussion.

Requirements
Skills Required

Background/experience

• At least 3 5 years' relevant manufacturing experience.
• National Diploma in Industrial Engineering or related discipline.
• At least 1 years Project Management Experience.
• At least 2 years Lean Manufacturing Experience.

Specific job skills

• Computer literacy
• Strong mechanical and process skills and a good working knowledge of control, logic and operational principles.
• Problem solving and action planning skills.
• Oral and written communication skills.
• Understanding of variable and period costs.

Competencies

• Meeting Deadlines
• Finalising Outputs
• Making Decisions
• Customer Awareness
• Interrogating Information