Biovac

2X QC Compliance Officer

Biovac  •  Cape Town, ZA (Onsite)  •  1 month ago
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Job Description

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

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.

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.''

Biovac

About Biovac

Biovac was founded in 2003 to revive and restore South Africa’s 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 we’ll only achieve this if we match scientific innovation through local biotechnology skills with the most advanced manufacturing technology and global partnerships. We work closely with local academic institutions, global pharmaceutical companies, the public sector as well as private sector. Some of our achievements are described below:

We manufacture highly advanced vaccines on behalf of leading international biopharmaceutical companies. Biovac is licensed to manufacture a fully liquid hexavalent vaccine from Sanofi that targets and protects against six childhood diseases. In 2021, we envisage to start the manufacture of a multivalent pneumococcal conjugate vaccine from Pfizer.

We supply over 15-million doses of vaccines a year in South Africa and neighbouring countries under strict cold chain conditions.

We have built inhouse product development capability and technologies and have successfully out-licensed one of our technologies to international manufacturers. We are working to establish new safeguards against pathogens like group B streptococcus bacteria, a rising cause of sepsis and meningitis in newborns.

To do this vital work, we rely on sophisticated technology and, above all, the skills and dedication of more than 350 highly trained team members. Along with our partners, we’ve invested over R800 million in infrastructure and skills development at our manufacturing facilities in Cape Town. These investments are resulting in estimated benefits of more than R500-million a year to the national economy.

Industry
Chemicals & Materials
Company Size
201-500 employees
Headquarters
Cape Town, ZA
Year Founded
2003
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