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.
• Quality and Regulatory compliance knowledge, i.e. SA GMP, PIC/S and WHO as well as application.

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.