2X QC Compliance Officer, Cape Town

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 2X QC Compliance Officer to join a goal-oriented team.

QUALIFICATIONS NEEDED

National Diploma in Analytical Chemistry, Microbiology, Biotechnology, Quality Management, or related field.

NECESSARY EXPERIENCE&INDUSTRY KNOWLEDGE

At least 2 to 4 years' experience within the pharmaceutical/ biotech manufacturing/ quality control or similar position.

Understanding of Pharmaceutical standards and compliance requirements.

Good understanding of Data Integrity principles (FDA 21 CFR Part 11 compliance, ALCOA++).

KEY DUTIES&RESPONSIBILITIES OF THE ROLE Core Technical Delivery

Ensure QC processes align with relevant regulatory bodies (e.g., GMP, GLP, ISO, WHO, SAHPRA, PIC/S standards).

Monitor and enforce compliance with SOPs, policies, and quality guidelines.

Participate in internal and external audits, providing required documentation and responses.

Support regulatory submissions by ensuring data accuracy and completeness.

Review laboratory documentation for completeness, accuracy, and adherence to data integrity principles (ALCOA+).

Maintain control and compliance of laboratory records, logs, and quality documentation.

Oversee deviations, non-conformances, and change control documentation.

Identify gaps or risks in QC processes and recommend corrective and preventive actions (CAPAs).

Assist in updating and drafting SOPs, work instructions, and quality manuals.

Support implementation of process improvements and efficiency measures.

Train QC staff on compliance requirements and updates.

Perform routine checks of laboratory operations, equipment logs, calibration records, and housekeeping standards.

Conduct periodic compliance risk assessments.

Track recurring issues and trends to support proactive quality planning.

Support investigations related to OOS (Out-of-Specification), OOT (Out-of-Trend), and deviations.

Application Deadline: 22 May 2026

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.

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