QA Operations Lead at Biovac

• 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 Operations Lead to join a goal-oriented team.

QUALIFICATIONS NEEDED:

• Bachelor's degree or diploma in Microbiology/ Biotechnology, Pharmacy or equivalent.

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

• At least 5 years' experience in vaccine/ biotech/ sterile or pharmaceutical manufacturing industry.
• At least 2 years' experience at middle management level in cGMP pharmaceutical manufacturing or equivalent
• Experience in quality and regulatory compliance within a cGMP facility
• Strong knowledge of sterile manufacturing environment
• Experience in having faced successful local and international quality audits

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

Core Technical Delivery:

• Ensure full QA operations oversight during all manufacturing operations. Escalate any critical incidents to the QA Manager.
• Ensure that departmental planning activities occur.
• Ensure QA shifts continuity and handovers take place to support all operational requirements.
• Lead significant investigations that can impact product Quality and patient safety.
• Lead significant risk assessment in accordance with ICH Q9.
• Lead, summaries, mitigate and present significant deviations to the applicant.
• Leads and participates in all QA engagement with external third-party stakeholders.
• Provide technical guidance to QA operations and site team on QMS processed.
• Ensures that obligations as set out in the Quality agreements are fulfilled during the QMS process.
• Ensure that significant changes to the facilities, equipment and processes, which may affect the quality of products, are managed via change management and validated.
• Ensure that procedures and specifications are appropriate and followed including the procedures and specifications of contract manufacturers, contract laboratories, etc.
• Approve site specifications and ensure that specifications are in line with pharmacopeial requirements.
• Review and approve significant out of specification investigations, out of trends investigation, protocols and reports within defined timelines as stated in SOPs.
• Co-ordinate and approve significant MDD and OOS investigations that may result in batch impact.
• Ensure that appropriate manufacturing controls, including master manufacturing and packaging documents are in place.
• Oversee customer and regulator audits and ensure tracking and closing findings, whilst maintaining appropriate communication between Biovac and auditors.
• Ensure timeous response to customer and regulatory inspections and audit reports.
• Work closely with the sterility assurance SME to ensure the controls are put in place to maintain Biovac contamination control strategy.
• Ensure that site complies with cGMP and is continuously improved on site in accordance with new defined guidelines.
• Participate and provide quality oversight within defined projects. Responsible for making Quality decisions linked with new projects.
• Ensure project deliverables delivered as per agreed timelines and quality.
• Responsible for specified QA processes and document systems including Deviations, CAPAs, Change Controls, National Regulatory Audits and Quality Risk Management.
• Review and approve documentation within defined timelines as stated in SOPs.
• Check the maintenance of the department, premises and equipment to ensure optimal operation at all times.
• 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.