QC Analyst: Chemistry

Biovac; Cape Town; On-site; ZAR 350,000 - 520,000; Full time

Benefits offered by this job

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Job summary

Biovac in Cape Town is seeking a Chemistry QC specialist to perform analyses on vaccines, raw materials and utilities, and to participate in technology transfers from other laboratories.

You will maintain cGMP compliant operations, support quality audits, draft and review procedures, and contribute to data analysis, trend reporting and continuous improvement across the site.

Qualifications

• Diploma or degree in Analytical chemistry, Biotechnology, Biochemistry or equivalent.
• Knowledge of relevant legislation and technical theory in field of study.

Responsibilities

• Implementing new tests and technologies and qualification of related equipment.
• Performing Chemistry testing for analytical development, verification and validation.
• Participating in technology transfers from vaccine manufacturers.
• Maintaining laboratory operations at cGMP standards for quality and compliance.
• Controlling stock related to Biological materials.
• Monitoring and maintaining Chemistry equipment.
• Drafting, updating and editing procedures for Chemistry testing.
• Sampling utilities and materials; Chemistry testing across stages.
• Reviewing raw data and compiling laboratory reports.
• Participating in audits and implementing corrective actions.
• Involvement with OOS/OOT investigations and communication of quality issues.
• Supporting Containment Control Strategy (CCS) implementation.

Skills

Laboratory skills

Documentation

Quality Management Systems

cGMP knowledge

Data analysis & reporting

Coaching & mentoring

Planning & organising

Communication skills

Education

Diploma or degree in Analytical chemistry, Biotechnology, Biochemistry or equivalent

Tools

LIMS

Microsoft Office

Job description

Job purpose

Responsible for Chemistry 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 Chemistry testing perspective.
• Introduction of new technologies related to Chemistry testing,
• Test verification and validation related to Chemistry 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 Chemistry testing perspective,
• Participation in quality audits,

• Responsible to deliver QC Analysis services and solutions in alignment with Pharmaceutical Quality System (PQS) requirements, related to Chemistry 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 Analytical chemistry, Biotechnology, Biochemistry or equivalent
• 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 Chemistry testing,
• Performing Chemistry testing, for analytical development, analytical verification, and analytical validation activities,
• Participating in technology transfers from other vaccine manufacturers and other project activities from a Chemistry perspective,
• Maintaining laboratory operations at cGMP standards to ensure quality, safety, and regulatory compliance,
• Controlling stock related to Biological,
• Monitoring equipment and maintenance of Chemistry equipment,
• Contributing to drafting, updating, proof reading and editing of procedures related to Chemistry testing,
• Sampling of utilities, routine, and non-routine,
• Chemistry testing, routine, and non-routine (including utilities testing, raw material, in process, final product testing and stability).
• Reviewing of laboratory raw data related to Chemistry testing,
• Compiling laboratory reports related to Chemistry testing,
• Completing trend analysis templates as laboratory results are obtained from a Chemistry perspective,
• Participate in departmental audits and implement corrective actions where relevant.
• Actively involved with OOS and/or OOT investigation related to Chemistry testing (internal or external testing) and ensuring that OOS and/or OOT investigations.
• Ensuring timely and effective communication by escalating quality issues to the appropriate levels of management, including DMS
• 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 elevate 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 elevate 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

Application closing date:

26 October 2026

If you do not receive a response from us within three weeks of submitting your application, 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.