QC Technical Specialist 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 QC Technical Specialist to join a goal-oriented team.

QUALIFICATIONS NEEDED:

• Min. Degree or diploma in Immunology / Biotechnology / Biochemistry or equivalent.
• Recognition is given to Prior Learning and practical experience.

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

• At least 3 years' experience in vaccine / pharmaceutical / biotech manufacturing industry with QC Laboratory.
• At least 1 year experience at supervisor level.
• Experience in quality and regulatory compliance within a cGMP facility.
• Experience in aseptic (sterile) manufacturing.
• Experience in having faced successful local and / or international quality audits (i.e., SAHPRA and WHO).
• Exposure and understanding of scientific principles related to vaccine manufacturing and testing.
• Experience in technical transfer activities applied to laboratories will be an advantage.

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

• Ensuring all gap analysis and risk assessments are completed for all laboratory activities.
• Can perform initial testing e.g. to ensure familiarization and successful execution.
• Procures new and existing materials required for successful execution of testing to agreed timelines.
• Driving continuous improvement plans and priorities through the implementation of appropriate tools or methodologies to proactively manage risk, reduce wastage and to improve quality on site.
• Planning and assisting with laboratory testing and troubleshooting.
• Co-ordinating testing of Stability, analytical verification and/or analytical validation samples related to associated activities.
• Compiling data trends, data analysis and associated reports to the correct standard and on-time.
• Reviewing of laboratory raw data and logbooks, including OOS/MDDs and or OOT results from internal and/or external testing.
• Ensuring that OOS and invalid investigations are initiated and completed to the correct standard.
• Training and upskilling of analysts.
• Training analysts on theoretical aspects testing with hands-on training approach by means of demonstration, and supervision, using test methods, SOPs, and other documentation and formal assessments.
• Performing formal competency assessments of performance, (e.g., Endotoxin, etc.)
• Selecting analytical test equipment for procurement and participating in equipment qualification e.g., review of qualification documents.
• Assisting in writing and updating of material and product specifications and test methods and standard operating procedures.
• Adhering to Pharmaceutical Quality System (PQS) requirements (e.g., SOPs, CAPAs, Deviations, Risk Assessments, and Change Controls.)
• Participating in quality audits and close out gaps and findings.
• Participating in inspections, investigations, risk management and quality review exercises.
• Participating testing related to technology transfers from other vaccine manufacturers and other project activities.
• Co-ordinating Data Integrity in the QC Laboratory testing with new and upcoming technologies (e.g., LIMS, new hardware and software programs, new technologies), when necessary.
• Co-ordinating Risk assessments in accordance with cGMP guidelines (e.g., ICH Q9, ICH Q10, etc.)
• Assisting with implementation of the site Containment and Control Strategy (CSS).

Application Deadline:

• 02 April 2025