Quality Assurance Officer

**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 Officer**to join a goal-oriented team. **QUALIFICATIONS NEEDED**: - Bachelor's degree or diploma in in Biotechnology, Pharmacy, Biological Sciences or a similar field. **NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE**: - At least 3 years' experience in Quality Assurance within the pharmaceutical/ biotech manufacturing industry. - Experience in quality management systems within a cGMP facility. - Experience in Production, Quality Control or relevant operational activities. - Sound technical ability in the field of operational Quality Assurance. **KEY DUTIES & RESPONSIBILITIES OF THE ROLE**: **Core Technical Delivery**: - Ensure 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 areas of responsibility on quality compliance requirements. - Contribute to discussion on relevant QA topics and communicate closely with other departments. - Participate in the investigation of incidents, OOS, deviations, discrepancies, root cause investigations or test failures as required. - Support allocated operational areas by participating in the implementation of change control. - Participate in Corrective Actions and Preventative Actions (CAPA) in order to meet compliance requirements. - Review, approval and closure of incidents in accordance with SOP. - Review, approval and closure of deviations and escalating to QA Operations Lead where relevant. - Review, approval and closure of change control for quality and regulatory compliance impact and determine requirements for implementation. - Review, approval and closure of MDDs and OOSs in accordance with SOP. - Participate in risk assessments and ensure mitigations are efficacious. - Ensure risk actions identified are closed timeously. - Assist in vendor auditing when required. - Perform internal audits as required, generate reports and follow up for close out of findings. - Support QA department with Regulatory audits and other 3rd party audits. - Ensure deep and holistic understanding of allocated area(s) of responsibility to ensure effective closure of critical auditing findings on site. - Ensure or develop understanding of processes in areas of responsibility to be able to review and sign off quality related documentation, such as SOPs, WI, etc. - Review batch records for compliance and adherence to GMP. - Perform QA checks in areas of responsibility and ensure that observations are documented and followed up. - Review and approve SOPs for responsible areas. - Review job descriptions of staff within area of responsibility. - Analyze and write regular trend reports. - Conduct Quality Forum meetings within area(s) of responsibility. - Assist in product quality reviews when required. - Ensure audit readiness. - Participate in projects as and when required. - Review and assess incidents raised. - Review and approval of effectiveness checks. - Labelling of product/material that is suspect according to internal procedures. - Ensure overdue QMS documents are followed up timeously and actioned. - Lead complex deviations/investigations on site to ensure adequate root cause and CAPA identification. - Providing training on GMP relevant aspects e.g., Quality Events, Change controls, CAPAs and Risk Management - Review effectiveness of the QMS to ensure the system remains in compliance. **Internal Application Deadline: 15 August 2025** **External Application Deadline: 29 August 2025** **_ Disclaimer:_