QC Supervisor: Biological Testing

Biovac; Cape Town; On-site; ZAR 200,000 - 300,000; Full time

Job summary

A leading sterile vaccine manufacturer in Cape Town seeks a dynamic QC Supervisor: Biological Testing. The role requires at least 4 years in sterile vaccine or biotech manufacturing, with a focus on quality control and regulatory compliance. Candidates should have experience in training and supervising laboratory staff. This position offers opportunities for professional growth and development in a supportive environment.

Qualifications

• At least 4 years of experience in sterile vaccine/pharmaceutical/biotech manufacturing.
• Minimum of 1 year experience at supervisor level.
• Experience in cGMP facility required.

Responsibilities

• Drive continuous improvement plans for quality and risk management.
• Plan and assist with routine laboratory testing.
• Co-ordinate testing of samples related to Biological testing.
• Compile trends and data analysis reports.
• Train and upskill analysts in Biological Testing.

Skills

Quality Control

Analytical Testing

Regulatory Compliance

Biological Testing

Continuous Improvement

Education

Degree or diploma in Immunology / Biotechnology / Biochemistry

Job description

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 Supervisor: Biological Testing to join a goal-oriented team.

QUALIFICATIONS NEEDED:

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

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:

• At least 4 years experience in sterile 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 is preferred.

KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

• 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 routine laboratory testing.
• Co-ordinating testing of Stability, analytical verification and/or analytical validation samples related to Biological testing and associated activities.
• Compiling data trends, data analysis and associated reports related to Biological testing 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 related to Biological testing.
• Ensuring that OOS/MDDs and OOT investigations are initiated and completed to the correct standard.
• Training and upskilling of analysts within Biological Testing.
• Training analysts on theoretical aspects of Biological 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 from a Biological perspective.
• Assisting in writing and updating of material and product specifications and test methods and standard operating procedures related to Biological testing.
• Participating in the selection and procurement of analytical test equipment and participation in equipment qualification (e.g., review of qualification documents.)
• 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 in Biological testing related to technology transfers from other vaccine manufacturers and other project activities.
• Ensuring that DMS queries are attended to and resolved within a reasonable time as the System Owner.
• Co-ordinating Data Integrity in the QC Laboratory with reference to Biological testing with new and upcoming technologies (e.g., LIMS, new hardware and software programs, new technologies), when necessary.
• Co-ordinating Biological 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), with reference to Biological testing.

We are an equal opportunities employer and welcome applications from all qualified candidates.