Quality Assurance Manager

**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 QA Manager to join a goal-oriented team. **QUALIFICATIONS NEEDED**: - Bachelors degree or diploma in Microbiology/ Biotechnology, Pharmacy, or equivalent. **NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE**: - At least 5-8 years of experience in the vaccine/ biotech/ or pharmaceutical manufacturing industry of which at least 3 years of sterile manufacturing experience is required. - At least 2-3 years of experience at the management level. - Experience in Training, Quality systems, and Quality operations disciplines - Experience in quality and regulatory compliance within a cGMP facility. - Business and operational planning. - Program and project management - Participation in developing a departmental budget and monitoring expenditures for multiple projects & funding sources. - Process understanding of sterile manufacturing facility. - Experience leading critical aseptic investigations and batch disposition assessments. **KEY DUTIES & RESPONSIBILITIES OF THE ROLE**: - Full responsibility for all areas within the Quality Assurance Operations sections consisting of Operations, Systems training, and projects. - Overall management and implementation of specified QA processes and document systems including Deviations, CAPAs, Change Controls, National Regulatory Audits, Quality Risk Management, and Trackwise Management. - Ensure that departmental planning activities occur. - Ensure that procedures and specifications are appropriate and followed including the procedures and specifications of contract manufacturers, contract laboratories, etc. - Ensure that significant changes to the facilities, equipment, and processes, which may affect the quality of products, are validated. - Ensure that appropriate manufacturing controls, including master manufacturing and packaging documents, are in place. - Evaluate and authorize any re-processing of products or materials. - Ensure that products are released in accordance with appropriate marketing authorization following full batch and testing record review. - Examine returned goods, to determine whether they should be released, reprocessed, or destroyed. - Ensure that a risk management program and principles are maintained in accordance with ICH Q9. - Participate in investigations in the event of a medicines recall and compile the relevant report. - Participate in the review of the effectiveness of the medicines recall procedure together with the Head of Quality and Responsible Pharmacist. - Review and approve out-of-specification investigations, out of trends investigations, protocols, and reports within defined timelines as stated in SOPs. - Review, approval and sign off all operational documents and records, e.g. System and Component Impact Assessments, GMP reviews, Design qualification, Risk Assessment, IQ, OQ, PQ, periodic re-qualification, Performance testing, Functionality testing Aseptic Process Validation, Process validation, Analytical Methods Validation, Cold-chain Packaging validation and Cleaning Validation documents, including both Protocols and Reports to ensure compliance with site approaches, cGMP and regulatory agency requirements. - Make batch disposition decisions in consultation with the Head of Department: Quality and Responsible pharmacist. - Actively participate in significant investigations including Aseptic investigations. - Benchmark against quality standards of industry and regulatory bodies and create awareness of GMP updates, as appropriate throughout the site. - Ensure that management review meetings are regularly held, and that appropriate metrics are monitored. - Oversee customer and regulator audits and ensure tracking and closure of findings, whilst maintaining appropriate communication between Biovac and auditors. - Assist in investigations of reported adverse drug reactions and provide a quality report to the Pharmacovigilance Officer. - As appropriate, write/review/approve/reject and/or control GMP Documentation and Records to ensure compliance with the requirements of the business, cGMP, and Regulatory agencies. - Ensure timeous response to customer and regulatory inspections and audit reports. - Participate in the investigation of quality-related complaints where needed. - Oversee the GMP training program at Biovac and ensure that training occurs in accordance with approved procedures. - Ensure that a training strategy is maintained for the site and that the training teams align processes and systems in line with the strategy. - Ensure Site compliance with the training program. - Manage the long-term archiving of documents and records and ensure that they are in place. - Manage activities in the Document Control Centre related to providing required documentation and implementing and maintaining related documentation systems. -