Job Opportunities at Biovac

• 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 QC Supervisor: Microbiology and Environmental Monitoring to join a goal-oriented team.

QUALIFICATIONS NEEDED:

• Degree or diploma in Microbiology / Biotechnology / Biochemistry or equivalent

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

• At least 3 years experience in vaccine / pharmaceutical / biotech manufacturing industry within the QC Laboratory,
• Experience in leading a team, planning and troubleshooting.
• Experience in quality and regulatory compliance within a cGMP facility

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

Core Technical Delivery:

• Driving continuous improvement plans and priorities through the implementation of appropriate tools or methodologies to proactively manage risk, reduce wastage and to improve quality on site.
• Co-ordinating all the testing and activities associated to ensure that the Environmental Monitoring Program is executed as per procedures for starting materials intermediate, bulk, and final products.
• Executing the Environmental Monitoring (EM) Program for assessing the manufacturing environment and utilities and escalating associated issues.
• Testing of Sterility samples, Stability testing, and analytical verification and/or analytical validation samples related to Microbiology testing & Environmental Monitoring.
• Identifying organisms related to Microbiology testing & Environmental Monitoring, and support the associated investigation, when necessary.
• Inspecting of Aseptic Process Simulations (APS) samples and associated activities.
• Compiling data trends, data analysis and associated reports for EM program to the correct standard and on time.
• Reviewing of laboratory raw data, including OOS/MDDs and or OOT results from internal and/or external testing related to Microbiology & Environmental Monitoring testing.
• Ensuring that OOS/MDDs and OOT investigations are initiated and completed to the correct standard.
• Training and upskilling of analysts within Microbiology Testing with hands-on training approach for analysts in theoretical aspects of Microbiology, and techniques by means of demonstration and supervision, using test methods, SOPs, and other documentation.
• Performing formal competency assessments of performance, (e.g., Sterility testing, etc.).
• Participate in the selection and procurement of analytical test equipment and participation in equipment qualification (e.g., review of qualification documents).
• Adhering to Pharmaceutical Quality System (PQS) requirements (e.g., SOPs, CAPAs, Deviations, Risk Assessments, and Change Controls).
• Participating in quality audits and close out gaps and findings.
• Participating in Microbiological & EM testing related to technology transfers from other vaccine manufacturers and other project activities.
• Participating in inspections, investigations, risk management and quality review exercises.
• Ensuring that DMS queries are attended to and resolved within a reasonable time as the System Owner.
• Co-ordinating Data Integrity in the QC Laboratory with reference to Microbiological & Environmental Monitoring testing with new and upcoming technologies (e.g., LIMS, new hardware and software programs, new technologies), when necessary.
• Co-ordinating Microbiological & EM Risk assessments in accordance with cGMP guidelines (e.g., ICH Q9, ICH Q10, etc).
• Assisting with implementation of the site Containment and Control Strategy (CSS), with reference to Microbiology & Environmental Monitoring.

Application Deadline: 21 November 2025

go to method of application »

• 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 Risk and Compliance Manager to join a goal-oriented team

QUALIFICATIONS NEEDED:

Required:

• Bachelors degree in risk management, Compliance, Law, Finance, Business Administration, or related discipline.
• Formal training or certification in Enterprise Risk Management (ERM), Corporate Governance, or Compliance Management (e.g., ISO 31000, COSO, or equivalent).

Preferred:

• Postgraduate diploma, honours degree, or masters qualification in Risk Management, Corporate Governance, Law, or Business Leadership.
• Professional membership or certification with: Institute of Risk Management South Africa (IRMSA), Compliance Institute SA, or Chartered Governance Institute of SA (CGISA).

Experience needed to deliver the role seamlessly:

• Minimum of 7 -10 years total professional experience in risk management, compliance, governance, or related fields, with at least 1 - 3 years in a managerial or leadership role.
• Proven experience implementing and maintaining Enterprise Risk Management frameworks within a corporate or regulated environment.
• Demonstrated exposure to compliance management, ethics and governance, and combined assurance processes.
• Practical experience in business continuity planning, risk reporting, and insurance or exposure analysis.
• Strong understanding of corporate governance codes (King IV/V), the Companies Act, and relevant sectoral regulations.
• Experience engaging senior management, preparing risk and compliance reports, and leading cross-functional initiatives.

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

Core Technical Delivery:

Enterprise Risk Management

• Lead the application of the ERM framework across all divisions and projects.
• Facilitate risk identification, evaluation, and treatment workshops with business leaders.
• Review and consolidate risk registers, ensuring consistent taxonomy, scoring, and mitigation tracking.
• Develop and monitor Key Risk Indicators (KRIs) and provide quarterly trend analyses.
• Oversee the Enterprise Risk Specialist in preparing dashboards, heat maps, and committee reports.

Business Continuity Management

• Oversee implementation and maintenance of the BCM framework.
• Ensure annual Business Impact Analyses (BIAs) are conducted and Business Continuity Plans (BCPs) are current.
• Lead organisation-wide continuity testing and scenario-planning exercises.
• Integrate BCM findings into ERM and performance reporting.

Compliance & Ethics

• Maintain Biovacs Compliance Framework, including risk-based compliance planning and monitoring.
• Oversee regulatory compliance registers, ensuring up-to-date legal and regulatory mapping.
• Support ethical governance, whistleblowing mechanisms, and conflict-of-interest management.
• Coordinate compliance awareness, training, and culture-building initiatives.
• Responsible for the development of a progressive training program for all incoming employees
• Responsible to ensure that there are adequate systems and processes in place to recognize gaps in existing processes or arising from new regulations and ensure that the correct remedial action is put into place to close the gaps.
• Responsible for the identification of potential compliance breaches and investigation of compliance irregularities or areas of concern, escalating significant issues to top management.
• Ensure that ethics procedures are followed, records are kept and reported incidents are closed out.

Insurance Risk Support

• Collaborate with the Finance Manager to ensure insurance cover aligns with organisational and project risks.
• Review risk data to inform renewal negotiations, coverage limits, and deductible levels.
• Provide technical input into insurance audits, claims, and post-incident risk reviews.
• Governance, Assurance & ESG Alignment
• Coordinate combined assurance activities across Risk, Compliance, ESG, and Internal Audit.
• Prepare consolidated risk and compliance reports for the Executive, Audit & Risk, and Board Committees.

People Management

• Provide leadership and guidance to the team.
• Establish clear roles, deliverables, and development plans aligned to departmental objectives.
• Monitor performance through regular feedback, coaching, and competency development.
• Foster a collaborative, high-performance culture grounded in ethical conduct and professional integrity.
• Ensure cross-functional collaboration with Legal, ESG, Internal Audit, and Finance teams etc.
• Oversee departmental resource planning, workload distribution, and succession preparedness.

Application Deadline: 03 December 2025

go to method of application »

• 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 3X- Validation Technician to join a goal-oriented team.

QUALIFICATIONS NEEDED:

• Completed qualification within any field of Natural/Health Sciences/ Engineering.

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

• Experienced in writing of technical documents.
• Basic experience in testing and troubleshooting practices.
• At least 6 months in a qualification / validation role within the pharmaceutical industry.

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

Core Technical Delivery:

• Liaising with service providers.
• Participate in Process Development activities.
• Execution of validation processes: PD, PV, CV, CSV, Mapping, Cold Chain, Facility Decontamination, Periodic Reviews and Periodic Revalidations as per defined timelines and according to cGMP
• Assist equipment owners with identifying maintenance and calibration requirements.
• Participates in troubleshooting a wide range of problems which require creative thinking. Exercises significant technical discretion in design, execution, and interpretation, and pursues new validation/qualifications studies as a result of experimental outcomes.
• Communication status and any delays/ issues/ changes experienced during validation.
• Communicate with departments regarding validation planning and time needed on validation activities.
• Provide guidance to staff from other departments regarding the required content of procedures.
• Manage internal customer relations and communication.
• Ensure relevant OOS and OOT investigation non-conformances/ deviations, change controls and CAPAs are initiated and completed to the correct standard.
• Identify quality risks in the section and initiate risk management where required, e.g. to support investigation or choices.

Application Deadline: 21 November 2025

go to method of application »

• 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 Data Integrity Officer to join a goal-oriented team.

QUALIFICATIONS NEEDED:

• Degree or Diploma in Computer Science, Information Technology, Information Systems, Engineering, Automation or related discipline.

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

• Experience in a pharmaceutical or biotechnology environment with a focus on qualification and validation specifically CSV, data integrity, quality assurance, or regulatory compliance.
• Understanding of regulatory requirements and guidelines related to CSV and data integrity.
• Analytical skills and attention to detail, with the ability to identify issues, analyze root causes, and implement effective solutions.
• Communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and communicate complex concepts to diverse audiences.

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

Core Technical Delivery:

• Liaising with internal and external service providers.
• Implement general DI and CSV activities and the associated strategy.
• Execute all DI and CSV activities according to the defined schedules.
• Follow CSV and DI qualification strategies as outlined and be the DI Lead.
• Execute CSV processes: DQ, Impact Assessment, IQ and OQ as per defined timelines in accordance to GAMP guidance.
• Assist system owners with identifying data maintenance requirements.
• Participate in troubleshooting discussions to investigate a wide range of challenges which requires creative thinking.
• Maintaining CSV and DI master plan / validation plan, schedules and other related documentation.
• Communicate DI and CSV status to the DI Lead on a regular basis.
• Escalate any delays/ issues/ changes experienced during DI and CSV task execution.
• Escalate with departments related to DI and CSV activity planning and allocated timelines.
• Provide critical information to staff from other departments related to the required content of procedures.
• Identify quality risks within CSV and DI and initiate risk management where required, e.g. to support investigation decisions.
• Partake in problems and new initiatives to ensure that a science & risk-based approach is adoptive to support.
• Ensure that SOPs, Plans and documents are up to date with the latest pharmaceutical and best practice guidelines.
• Ensure Deviations, Incidents, Change Controls, CAPAs, audit findings, RAs related to DI and CSV are handled effectively.
• Ensure that the DI and CSV schedule are in place, communicated, updated and delivered on according to defined timelines.
• Support the Data Integrity Lead with DI and CSV strategy and associated department goals setting.
• Partake in activities performed by external stakeholders according to defined schedules.
• Engage in investigations linked to DI and CSV activities.

Application Deadline: 21 November 2025

go to method of application »

• 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 Data Integrity Lead to join a goal-oriented team.

QUALIFICATIONS NEEDED:

• Degree or Diploma in Computer Science, Information Technology, Information Systems, Engineering, Automation or related discipline.

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

• 3-5 years of experience in a pharmaceutical or biotechnology environment with a focus on qualification and validation specifically CSV, data integrity, quality assurance, or regulatory compliance.
• Strong understanding of regulatory requirements and guidelines related to CSV and data integrity (e.g., FDA CFR Part 11, Annex 11, GAMP).
• Experience with electronic document management systems (EDMS), laboratory information management systems (LIMS), and other electronic data capture systems.
• Excellent analytical skills and attention to detail, with the ability to identify issues, analyse root causes, and implement effective solutions.
• Strong communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and communicate complex concepts to diverse audiences.

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

Core Technical Delivery:

• Liaising with internal and external service providers.
• Define general DI and CSV activities and the associated strategy.
• Ensure execution of all DI and CSV activities according to the defined schedules.
• Define CSV and DI qualification approaches to new equipment for site.
• Ensure execution of Qualification processes: DQ, Impact Assessment, IQ and OQ as defined timelines in accordance with GAMP guidance.
• Assist system owners with identifying information maintenance requirements.
• Participate in and lead troubleshooting discussions to investigate a wide range of challenges which require creative thinking.
• General administration such as updating of the master plan / validation plan, maintaining schedules, standard referencing of documentation.
• Exercise significant technical discretion in design, execution, and interpretation, and pursues new studies as a result of experimental outcomes.
• Communicate DI and CSV status to the business on a regular basis.
• Communicate any delays/ issues/ changes experienced during DI and CSV task execution.
• Communicate with departments related to DI and CSV activity planning and allocated timelines.
• Provide guidance to staff from other departments related to the required content of procedures.
• Identify quality risks in the section and initiate risk management where required, e.g. to support investigation decisions.
• Provides scientific input into problems and new initiatives to ensure that a science & risk-based approach is adoptive to support.
• Ensure that SOPs, Plans and documents are up to date with the latest pharmaceutical and best practice guidelines.
• Ensure Deviations, Incidents, Change Controls, CAPAs, audit findings, RAs related to DI and CSV are handled effectively.
• Ensure that the DI and CSV schedule are in place, communicated, updated and delivered on according to defined timelines.
• Support the Validation Manager with DI and CSV strategy and associated department goals setting.
• Provide guidance and oversight for activities performed by external stakeholders according to defined schedules.
• Lead significant investigations linked to DI and CSV activities.

Application Deadline: 29 November 2025