Biovac was founded in 2003 to revive and restore South Africas vaccine manufacturing capabilities. We are an African based manufacturer contributing towards filling the gap that exists in the lack of African vaccine manufacturing capability. We recognise that well only achieve this if we match scientific innovation through local biotechnology skills with ...
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- BIOVAC is one of the leading sterile vaccine manufacturers rooted in Africa, with our core purpose being to "protect life". We are looking to hire a dynamic, passionate, confident, proactive and QC Supervisor: Chemistry to join a goal-oriented team.
QUALIFICATIONS NEEDED:
- Diploma or degree in Analytical Chemistry, Chemistry or equivalent.
- Recognition is given to Prior Learning and practical experience.
NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:
- 3+ years experience in a pharmaceutical QC laboratory or equivalent of which at least one year should be at Senior Analyst level.
- 1 years Supervisory experience in pharmaceutical quality control or similar position would be an advantage.
- Quality and regulatory compliance knowledge, i.e. SAHPRA and WHO would be an advantage.
- Experience in having faced successful local and international quality audits would be an advantage.
KEY DUTIES & RESPONSIBILITIES OF THE ROLE:
- To ensure that the chemistry testing related activities are performed at the required quality levels (TBI, SAHPRA and WHO), within the agreed / budgeted time frame.
- Ensure undisrupted, punctual and safe operation of staff and processes pertaining to raw material release, finished products, intermediates, utilities and stability testing.
- Continually strive to deliver solutions through teamwork that ensures continuous improvement through innovative solutions.
- Active guidance and coaching of staff within section.
- Participating in project teams and supporting other relevant organisational departments.
- Ensuring compliance in accordance with the Medicines and Related Substances Act 101 of 1965, Pharmacy Act 53 of 1974 and the organizations policies, procedures and other applicable laws.
- Participation in quality audits and support to validation teams.
- Effective implementation of quality systems.
- Raw Material, intermediates, utility, stability and finished product testing.
- Ensuring that all EHS related issues are in order and responsible for Safety Reps.
- Ensure Change controls, Deviations, CAPAs and Risk Assessments are closed on time.
- Investigate all OOS/OOT generated in the Chemistry section.
Data Integrity Compliance:
- Ensure all laboratory data is recorded, reviewed, and stored in accordance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available).
- Promote a culture of data integrity by training staff on proper documentation practices and electronic data handling.
- Monitor and audit data management systems to detect and prevent data manipulation, omissions, or unauthorized access.
- Support implementation of secure, validated systems for electronic records and signatures in compliance with 21 CFR Part 11 and other applicable regulations
Application Deadline: 20 August 2025
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- BIOVAC is one of the leading sterile vaccine manufacturers rooted in Africa, with our core purpose being to "protect life". We are looking to hire a dynamic, passionate, confident, proactive and meticulous Quality Assurance Officer to join a goal-oriented team.
QUALIFICATIONS NEEDED:
- Bachelor's degree or diploma in in Biotechnology, Pharmacy, Biological Sciences or a similar field.
NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:
- At least 3 years' experience in Quality Assurance within the pharmaceutical/ biotech manufacturing industry.
- Experience in quality management systems within a cGMP facility.
- Experience in Production, Quality Control or relevant operational activities.
- Sound technical ability in the field of operational Quality Assurance.
- Quality and Regulatory compliance knowledge, i.e. SA GMP, PIC/S and WHO as well as application.
KEY DUTIES & RESPONSIBILITIES OF THE ROLE:
Core Technical Delivery:
- Ensure compliance with all applicable regulations and internal procedures by proactively interpreting regulatory and quality requirements and determining the way of working.
- Coach and provide QA leadership to areas of responsibility on quality compliance requirements.
- Contribute to discussion on relevant QA topics and communicate closely with other departments.
- Participate in the investigation of incidents, OOS, deviations, discrepancies, root cause investigations or test failures as required.
- Support allocated operational areas by participating in the implementation of change control.
- Participate in Corrective Actions and Preventative Actions (CAPA) in order to meet compliance requirements.
- Review, approval and closure of incidents in accordance with SOP.
- Review, approval and closure of deviations and escalating to QA Operations Lead where relevant.
- Review, approval and closure of change control for quality and regulatory compliance impact and determine requirements for implementation.
- Review, approval and closure of MDDs and OOSs in accordance with SOP.
- Participate in risk assessments and ensure mitigations are efficacious.
- Ensure risk actions identified are closed timeously.
- Assist in vendor auditing when required.
- Perform internal audits as required, generate reports and follow up for close out of findings.
- Support QA department with Regulatory audits and other 3rd party audits.
- Ensure deep and holistic understanding of allocated area(s) of responsibility to ensure effective closure of critical auditing findings on site.
- Ensure or develop understanding of processes in areas of responsibility to be able to review and sign off quality related documentation, such as SOPs, WI, etc.
- Review batch records for compliance and adherence to GMP.
- Perform QA checks in areas of responsibility and ensure that observations are documented and followed up.
- Review and approve SOPs for responsible areas.
- Review job descriptions of staff within area of responsibility.
- Analyze and write regular trend reports.
- Conduct Quality Forum meetings within area(s) of responsibility.
- Assist in product quality reviews when required.
- Ensure audit readiness.
- Participate in projects as and when required.
- Review and assess incidents raised.
- Review and approval of effectiveness checks.
- Labelling of product/material that is suspect according to internal procedures.
- Ensure overdue QMS documents are followed up timeously and actioned.
- Lead complex deviations/investigations on site to ensure adequate root cause and CAPA identification.
- Providing training on GMP relevant aspects e.g., Quality Events, Change controls, CAPAs and Risk Management
- Review effectiveness of the QMS to ensure the system remains in compliance.
Application Deadline: 29 August 2025
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- As BIOVAC expands its manufacturing base it will embark on a large facility expansion project in Cape Town spanning over the next 10 years. The project is distributed over several phases and aims to build and expand on Biovac s sterile manufacturing capability in vaccines across the full value chain. To facilitate this Biovac is looking for exceptional project skills and expertise in a range of disciplines within sterile pharmaceutical manufacturing. We are looking to hire a dynamic, passionate, confident, proactive and meticulous Control and Automation Lead (Projects) to join a goal orient.
QUALIFICATIONS NEEDED:
- Eng., B.Sc. or BTech degree in Electrical/Mechatronic/Electronic Engineering or equivalent.
NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:
- Min 3 years management experience in cGMP vaccine/pharmaceutical manufacturing or similar position.
- Sound experience in project management.
- Experience in general business management.
- Sound technical ability and hands on approach on qualification activities.
KEY DUTIES & RESPONSIBILITIES OF THE ROLE:
- Sound knowledge on Siemens S7 PLC fault finding and Basic programming, Siemens WinCC and ProTool, Wonderware.
- Knowledge of Industrial PCs and / Soft PLC controlled systems is compulsory.
- Instrumentation and equipment calibration experience is required.
- Strong fault findings skills and problem solving is required.
- InTouch Scada systems, Historian (SQL Databases) and System Platform.
- Communication protocols: Profibus, Modbus, Profinet, OPC etc.
- GAMP 5: Risk based approach to Compliant GxP computerized systems
- Responsible for the management of the planned and preventative maintenance function on the site
- Utilizing information technology as a design aid for replacement, and maintenance strategies for mechanical and Utilities engineering services
- utilizing information technology as a design aid for replacement, and maintenance strategies for mechanical and filling formulating and finish production equipment
- Establish world class best practice and implement changes to achieve these in the above-mentioned areas
- Life cycle costing; Implementation of PM strategy
- Proactively mitigate general business as well as areas of responsibility- related risks and find ways to mitigate these.
- Ensure the relevant expertise and current Good Manufacturing Practices (cGMP) alignment exists within the teams.
- Lead or participate in departmental and/or site wide projects.
- Monitoring & reporting on key operations, critical numbers and key performance indicators that impact on the businesss short, medium- and long-term objectives.
- Lead organizations transition into commercial operations and mind-set as well as institute this across site with regards to managing efficiencies, reducing wastage, and contributing to overall profitability.
- Ensure maintenance activities are performed in compliance of SA GMP (Good Manufacturing Practices) guide including GEP activities. Maintenance schedules in place for all equipment/ systems on site.
Application Deadline: 29 August 2025
go to method of application »
- As BIOVAC expands its manufacturing base it will embark on a large facility expansion project in Cape Town spanning over the next 10 years. The project is distributed over several phases and aims to build and expand on Biovac s sterile manufacturing capability in vaccines across the full value chain. To facilitate this Biovac is looking for exceptional project skills and expertise in a range of disciplines within sterile pharmaceutical manufacturing. We are looking to hire a dynamic, passionate, confident, proactive and meticulous Senior Process Lead (Projects) to join a goal orient.
QUALIFICATIONS NEEDED:
- Bachelors or higher degree in chemistry/biotechnology/pharmacy/chemical engineering or equivalent.
NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:
- Good working knowledge of aseptic (sterile) manufacturing processes.
- At least 10 years of process, equipment and project design and execution experience within the sterile pharmaceutical /biotech manufacturing industry.
- Experience in managing and executing multi-disciplinary projects in excess of R100 million.
- Excellent understanding of process flows and key metrics within a sterile manufacturing environment.
- Excellent understanding of the cGMP guideline relating to sterile products.
- Experience in initiating, planning, executing, and closing projects.
- Experience in, the control and monitoring of project progress and risks.
KEY DUTIES & RESPONSIBILITIES OF THE ROLE:
- Ensures that projects are properly scoped with clearly defined deliverables and clear execution plans.
- To execute the full range of technical project activities including design, scoping, budgeting, scheduling and execution for successful delivery in line with organizational requirements.
- To develop technical standards and user requirement specifications.
- Identify and escalate risks and mitigation/recovery plans.
- Create project budget and ensure adherence to the prescribed budget.
- Request approval for changes from necessary stakeholders and manage changes via project change request processes.
- Ensure that the quality criteria are properly defined for each deliverable and frequently measured and reported.
- Ensuring all designs are cost effective and value adding for Biovac.
- Execute/provide technical advice for process and/or equipment processes.
- Conduct manufacturer visits to perform design reviews, risk analysis, FAT as well as receive training from manufacture for the relevant equipment.
- Compile the necessary documentation upon completion of manufacturer visit and training.
- Conduct the necessary research in order to contribute towards ensuring that the process equipment (new equipment) is qualified (IQ, OQ) and ready for production activities within the project timelines.
- Process equipment SOPs, specifications, qualification documents and MBRs are generated through the appropriate review process and in place for production within the required timeline.
- Ensures that the project delivery is in line with agreed Sterile Products cGMP guidelines.
- Ensures process design meets quality criteria.
Application Deadline: 29 August 2025
go to method of application »
- As BIOVAC expands its manufacturing base it will embark on a large facility expansion project in Cape Town spanning over the next 10 years. The project is distributed over several phases and aims to build and expand on Biovac's sterile manufacturing capability in vaccines across the full value chain. To facilitate this Biovac is looking for exceptional project skills and expertise in a range of disciplines within sterile pharmaceutical manufacturing. We are looking to hire a dynamic, passionate, confident, proactive and meticulous Senior Technical Lead (Utilities) to join a goal orient.
QUALIFICATIONS NEEDED:
- Bachelors or higher degree in chemistry/biotechnology/pharmacy/chemical engineering or equivalent.
NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:
- Good working knowledge of aseptic (sterile) manufacturing processes.
- At least 10 years of process, equipment and project design and execution experience within the sterile pharmaceutical /biotech manufacturing industry.
- Experience in managing and executing multi-disciplinary projects in excess of R100 million.
- Excellent understanding of process flows and key metrics within a sterile manufacturing environment.
- Excellent understanding of the cGMP guideline relating to sterile products.
- Experience in initiating, planning, executing, and closing projects.
- Experience in, the control and monitoring of project progress and risks.
KEY DUTIES & RESPONSIBILITIES OF THE ROLE:
- Ensures that projects are properly scoped with clearly defined deliverables and clear execution plans.
- To execute the full range of technical project activities including design, scoping, budgeting, scheduling and execution for successful delivery in line with organizational requirements.
- To develop technical standards and user requirement specifications.
- Identify and escalate risks and mitigation/recovery plans.
- Create project budget and ensure adherence to the prescribed budget.
- Request approval for changes from necessary stakeholders and manage changes via project change request processes.
- Ensure that the quality criteria are properly defined for each deliverable and frequently measured and reported.
- Ensuring all designs are cost effective and value adding for Biovac.
- Execute/provide technical advice for process and/or equipment processes.
- Conduct manufacturer visit to perform design reviews, risk analysis, FAT as well as receive training from manufacturer for the relevant equipment.
- Compile the necessary documentation upon completion of manufacturer visit and training.
- Conduct the necessary research in order to contribute towards ensuring that the process equipment (new equipment) is qualified (IQ, OQ) and ready for production activities within the project timelines.
- Process equipment SOPs, specifications, qualification documents and MBRs are generated through the appropriate review process and in place for production within the required timeline.
- Ensures that the project delivery is in line with agreed Sterile Products cGMP guidelines.
- Ensures process design meets quality criteria.
Application Deadline: 29 August 2025
go to method of application »
- As BIOVAC expands its manufacturing base it will embark on a large facility expansion project in Cape Town spanning over the next 10 years. The project is distributed over several phases and aims to build and expand on Biovac s sterile manufacturing capability in vaccines across the full value chain. To facilitate this Biovac is looking for exceptional project skills and expertise in a range of disciplines within sterile pharmaceutical manufacturing. We are looking to hire a dynamic, passionate, confident, proactive and meticulous Strategic Project Lead to join a goal orient.
QUALIFICATIONS NEEDED:
- Bachelors or higher degree in engineering/biotechnology/pharmacy/ or equivalent.
- Business Qualification is an advantage.
- Project Management qualification is an advantage.
NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:
- Minimum of 10 years of experience with sterile pharmaceutical /biotech manufacturing.
- Experience in managing and executing multi-disciplinary projects of at least R 250 million.
- Excellent working knowledge of sterile pharmaceutical manufacturing processes.
- Excellent understanding of process flows and key operational metrics withing a sterile manufacturing environment
- Excellent understanding of the cGMP guideline relating to sterile products.
KEY DUTIES & RESPONSIBILITIES OF THE ROLE:
- Ensures that strategic projects are fully scoped with clearly defined deliverables and clear execution plans.
- Execution of strategic project activities including design, scoping, budgeting, scheduling, and execution for successful delivery in line with Biovac s strategic objectives. Strategic projects are typically a 5 10 years duration and between R1.5 and R5 billion in value.
- Accountable for the appointment and direct management of the 3rd party Design and Build Engineering supplier.
- Accountable for the development and execution of the change management plan.
- Development of technical standards and user requirement specifications.
- Identify and escalate risks and mitigation/recovery plans.
- Create project budget and ensure adherence to the prescribed budget.
- Requests approvals for changes from necessary stakeholders and manages changes via project change request processes.
- Ensure that the quality criteria is properly defined for each deliverable and frequently measured and reported.
- Ensuring all designs are cost effective and value adding for Biovac.
- Responsible for the leadership of the strategic projects team.
- Responsible for the development of skills and capabilities of this team aligned with Biovac's current and future strategic objectives.
- Conduct business, cross functional and departmental planning and execute activities within own scope of accountability.
- Adequate capacity planning and performance delivery in line with strategic, tactical, and operational plans.
- Role profiling, goal setting and performance management of senior technical leads and staff within the department.
- Ensures that the project delivery is in line with agreed Sterile Products cGMP guidelines.
- Ensures process design meets quality criteria.
Application Deadline: 29 August 2025
Method of Application
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