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

Quality Assurance Outsource Officer

to join a goal-oriented team.

QUALIFICATIONS NEEDED:

Degree or Diploma in Biotechnology, Pharmacy, Biological Sciences, or a similar field.

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

At least 5 years' experience in Quality Assurance within the pharmaceutical/ biotech manufacturing industry. Experience in quality management systems within a cGMP facility. Sound technical ability in the field of operational Quality Assurance. Quality and Regulatory compliance knowledge, i.e., SA GMP, PIC/S and WHO as well as application.

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

Core Technical Delivery:

Compliance with all applicable regulations and internal procedures by proactively interpreting regulatory and quality requirements and determining the way of working. Coach and provide QA leadership to staff with regards to vendor management. Submit appropriate weekly, monthly and quarterly, quality and operation metrics. Write, review, and approve SOPs and Work instructions related to the outsource section. Ensure annual reports are completed where required. Conduct vendor certifications, reviews and approvals and manage the vendor database and AVL up to dates. Review and approve GMP specifications. Establish and maintain a risk-based approach and review of approved vendors by conducting quality risk assessments for approved vendors. Plan, conduct and coordinate internal audits including establishing audit teams, peer review of observations and follow up with departments on. open actions, writing the annual report for internal audits. Plan, conduct and coordinate external (supplier/vendor, customer, and third-party manufacturers) audits including establishing of audit teams, peer. review of observations and follow up of open vendor CAPAs and ensure closure of audit findings. Review and approve internal, vendor and postal audits. Compile and review quality technical agreements for approval for supplier/vendor, customers, and third-party manufacturers. Create tracking mechanisms to manage all quality contracts for the department. Compile and review contracts with all agents that Biovac exports to. Coordinate regulatory audits, support QA Release and Outsource Manager Regulatory audits, and ensure that CAPA plans are in place and timeously executed for observation found. Request master documents from third-party manufacturers. Update Site Master File as per regulatory requirements. Manage and coordinate change notifications from vendors, 3rd party manufacturers. Liaise with other support departments on site to drive the change notifications from vendors and 3rd party manufacturers. Create, coordinate, and manage artwork activities within Biovac. Coordinate communication of artwork changes to third-party manufacturers. Investigate and compile investigation reports relating to vendor quality complaints. Communicate investigations and outcomes of vendor quality complaints to external state holders. Compile vendor monitoring reports as per approved vendor monitoring program.

Internal Application Deadline: 08 August 2025

External Application Deadline: 15 August 2025

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.