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HEAD (ASSOCIATE PROFESSOR/PROFESSOR) DIVISION OF MEDICAL MICROBIOLOGY DEPARTMENT OF PATHOLOGY FACULTY OF HEALTH SCIENCES UNIVERSITY OF CAPE TOWN (UCT) & NATIONAL HEALTH LABORATORY SERVICES (NHLS) The University of Cape T…
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Biovac
Cape Town, Western Cape, South Africa • On-site
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The QC Analyst is responsible for performing biological testing on products and raw materials while ensuring laboratory operations comply with cGMP and GLP standards. They will also participate in technology transfers, equipment qualification, and the investigation of out-of-specification results.
Candidates must hold a diploma or degree in Microbiology, Biotechnology, or Biochemistry. At least 1-3 years of experience in a vaccine, pharmaceutical, or biotech manufacturing QC laboratory is required.
Job purpose
Responsible for Biological testing activities including but not limited to:
QC Biological testing of products, raw materials, utilities, and other samples.
Participation in technology transfers from other laboratories from a Biological testing
perspective.
Introduction of new technologies related to Biological testing,
Test verification and validation related to Biological testing,
Continually strive to deliver solutions through teamwork that ensures continuous
improvement through innovative solutions.
Achieving/ maintaining of the facilities and processes in full compliance with the current
regulations and guidelines – both local and international.
Participating in project teams and supporting other relevant organizational departments and/ or teams from a Biological testing perspective,
Participation in quality audits,
Responsible to deliver QC Analysis services and solutions in alignment with Pharmaceutical Quality System (PQS) requirements, related to Biological testing,
Ensure compliance in accordance with the Medicines and Related Substances Act 101 of 1965 and the Pharmacy Act 53 of 1974, and the organization’s policies, procedures, and other applicable laws.
Continuously build and support a sound quality assurance culture aligned to cGMP within Biovac,
Responsible for QC Administrative activities to ensure product quality including but not limited to: Support to QC activities to ensure product quality.
Maintaining laboratory operations at cGMP, GLP standards to ensure quality, safety, and regulatory compliance.
Continually strive to deliver solutions through teamwork that ensures continuous improvement through innovative solutions.
Achieving/ maintaining of the facilities and processes in full compliance with the current regulations and guidelines – both local and international.
Responsible to ensure that the QC department and its respective sections deliver services and solutions in alignment with pharmaceutical quality system requirements.
Ensure compliance in accordance with the Medicines and Related Substances Act 101 of 1965 and the Pharmacy Act 53 of 1974, and the organization’s policies, procedures, and other applicable laws.
Continuously build and support a sound quality assurance culture aligned to cGMP within Biovac.
Minimum qualification(s)
Required:
Diploma or degree in Microbiology, Biotechnology, Biochemistry or equivalent (Micro & Biological Testing)
Knowledge and understanding of relevant legislation and technical theory in field of study.
Preferred:
Recognition is given to Prior Learning and practical experience.
Experience & industry knowledge
Required:
- At least 1- 3 years’ experience in vaccine / pharmaceutical / biotech manufacturing industry
with QC Laboratory,
- Demonstrated competency in laboratory skills, including documentation,
- Experience in quality and regulatory compliance within a cGMP facility.
Preferred:
- Working knowledge of Pharmaceutical related legislation
- Previous participation in quality audits
- Experience in aseptic (sterile) manufacturing
- Working knowledge of testing techniques in instruments in Biological
Key Duties & Responsibilities
Routine Activities
(Including but not limited to):
Implementing new tests and new technologies and participation in the qualification of related equipment related to Biological testing,
Performing Biological testing, for analytical development, analytical verification, and analytical validation activities,
Participating in technology transfers from other vaccine manufacturers and other project activities from a Biological perspective,
Maintaining laboratory operations at cGMP standards to ensure quality, safety, and regulatory compliance,
Controlling stock related to Biological,
Monitoring equipment and maintenance of Biological equipment,
Contributing to drafting, updating, proof reading and editing of procedures related to Biological testing,
Sampling of utilities, routine, and non-routine,
Biological testing, routine, and non-routine (including utilities testing, raw material, in process, final product testing and stability).
Reviewing of laboratory raw data related to Biological testing,
Compiling laboratory reports related to Biological testing,
Completing trend analysis templates as laboratory results are obtained from a Biological perspective,
Participate in departmental audits and implement corrective actions where relevant.
Actively involved with OOS and/or OOT investigation related to Biological testing (internal or external testing) and ensuring that OOS and/or OOT
investigations are completed on time, and to the correct standard,
Ensure that DMS queries are attended to within a reasonable time as the System Owner, and escalated to Laboratory Supervisors and
management,
Ensuring timely and effective communication by escalating quality issues to the appropriate levels of management, including DMS
Excursions
Assisting with implementation of the Containment Control Strategy (CCS) for the site.
Technical Competencies required to perform this aspect of the role:
Computer Literacy and a good working knowledge of Microsoft office,
Basic understanding of legislation relating to documentation
Basic understanding of legislation relating to reporting requirements
Detailed knowledge of pharmaceutical industry standards and guidelines in cGMP, Quality and Laboratory Management.
Laboratory skills and techniques
Report writing skills,
Quality Management Systems
Environmental, Health & Safety management.
Statistical trending, data analysis & reporting,
Coaching & mentoring of peers.
Supporting Quality Management
Building own cGMP knowledge and compliance
Participate in achieving the company’s quality objectives.
Participate in building a sustainable quality culture on site and proactive mitigate risks that may negatively impact quality or escalate these
appropriately.
Establish and maintain a state of control related to quality management within the department.
Ensuring audit readiness within own role through closing out audit findings timeously
Ensure Deviations, Change Controls, CAPAs are handled effectively,
Advocate continuous improvement,
Technical Competencies required to perform this aspect of the role:
cGMP knowledge
Total Quality Management & Quality Management Systems
Data development, trending & reporting
Coaching & mentoring peers & staff
Generic Competencies required to perform this role:
Planning, Organising, Execution & Delegation
Strategic & Holistic Thinking
Creative Problem Solving & Innovation Skills
Sustainable Stakeholder Management
Action & Results Oriented
Assertive & Resilient
Adaptable in Responding to change
Proactive in mitigating risk
Clear, timely and effective communication skills both verbally and in writing
Analytical Ability
Quality Management
Building own, team and site’s GMP Knowledge and Compliance
Participate in building quality objectives and provide ongoing metrics that directly support the achievement of such objectives.
Participate in building a sustainable Quality Culture on site and proactive mitigate risks that may negatively impact quality or escalate these appropriately.
Establish and maintain a state of control related to quality management within the department
Ensuring that the department is audit ready through closing out audit findings timeously
Ensure Deviations, Change Controls, CAPAs are handled effectively
Advocate continuous improvement within own department as well as cross functionally
Technical Competencies required to perform this aspect of the role:
cGMP vaccine manufacturing- quality and regulatory compliance knowledge, i.e. MCC and WHO
Total Quality Management & Quality Management Systems
Data development, trending & reporting
Coaching & mentoring peers & staff
Application Deadline: 7 August 2026
If you do not receive a response from us within three weeks after closing date, please understand that your application was not successful.
We believe in the magic of diversity within teams and to achieve this, we do apply Employment Equity principles during our selection process where this is necessary to achieve such diversity.
Disclaimer:
Dear Applicant, we appreciate your interest in joining our organization. It is imperative for us that you understand how we handle your information. We are committed to ensuring the security and confidentiality of the information you provide. Your personal details will be collected for the sole purpose of the application process and will be used strictly for that purpose. By applying, you acknowledge and consent to the collection, use, and protection of your personal information in accordance with our privacy policy. If you have any inquiries or concerns, our Human Capital department is available to provide clarification. We look forward to reviewing your application.’’
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