QA Outsource Officer

1 week ago

Cape Town, South Africa Biovac Full time

**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. **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** **_ Disclaimer:_

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