About Biovac

Biovac is a bio-pharmaceutical company based in Cape Town that is the result of a partnership formed with the South African government in 2003 to establish local vaccine manufacturing capability for the provision of vaccines for national health management and security. At Biovac we are committed to making South Africa and the rest of Africa more self-reliant in vaccine development and manufacturing through the science of protecting life. Our solid partnerships with international vaccine R&D and manufacturing organisations have allowed us to bring innovative technologies to the continent.

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.