QC Technical Specialist X2
Introduction
BIOVAC, a leading sterile vaccine manufacturer rooted in Africa with a core purpose to “protect life,” is looking to hire two dynamic, proactive, and meticulous QC Technical Specialists to join our goal-oriented team. If you are passionate about contributing to Africa’s vaccine security and thrive in a fast-paced, quality-focused environment, we encourage you to apply.
Location: Cape Town (BIOVAC)
Closing Date: 30 July 2025
Qualifications
- Degree or diploma in Immunology, Biotechnology, Biochemistry, Chemistry, or equivalent.
- Recognition given to Prior Learning and practical experience.
Experience & Industry Knowledge
- Minimum 3 years in vaccine/pharmaceutical/biotech manufacturing in a QC Laboratory.
- At least 1 year in a supervisory role.
- Experience with quality and regulatory compliance in a cGMP facility.
- Exposure to aseptic (sterile) manufacturing environments.
- Experience with SAHPRA and WHO audits.
- Understanding scientific principles related to vaccine manufacturing and testing.
- Experience in technical transfer activities (advantageous).
Key Duties & Responsibilities
- Perform gap analyses and risk assessments for lab activities.
- Execute initial testing to ensure familiarity with processes.
- Procure materials for successful testing within timelines.
- Drive continuous improvement to manage risk and improve quality.
- Plan, assist, and troubleshoot laboratory testing.
- Coordinate stability, analytical verification, and validation testing.
- Compile data trends, analyses, and reports to standards and deadlines.
- Review laboratory raw data, logbooks, OOS/MDD/OOT results.
- Ensure timely and standard completion of OOS and invalid investigations.
- Train and upskill analysts on theoretical and hands-on testing, SOPs, and assessments.
- Perform competency assessments on analysts (e.g., Endotoxin testing).
- Participate in equipment procurement and qualification.
- Assist in writing and updating SOPs, material, and product specifications.
- Adhere to Pharmaceutical Quality System requirements.
- Participate in audits, inspections, investigations, and quality reviews.
- Support testing for technology transfers and new project activities.
- Coordinate Data Integrity within QC testing, including LIMS and new technologies.
- Coordinate risk assessments aligned with cGMP guidelines (e.g., ICH Q9, ICH Q10).
- Assist with implementation of Containment and Control Strategy (CSS).
Why Join BIOVAC?
- Contribute to Africa’s vaccine manufacturing capability.
- Be part of a collaborative, purpose-driven, and dynamic team.
- Work in an environment that values diversity and continuous improvement.
- Opportunity to grow within a quality and science-focused organization.
If you are ready to use your skills to protect life and advance healthcare in Africa, submit your application before the closing dates listed above. Should you not hear from us within three weeks of applying, please consider your application unsuccessful. At BIOVAC, diversity is valued, and Employment Equity principles are applied where necessary to strengthen our teams. We are committed to ensuring the security and confidentiality of your personal information during the recruitment process.
Closing Date: 30 July 2025
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