Quality Assurance Manager

2 weeks 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 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.
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