QC Technical SpecialistBiovac • Cape Town, Western Cape, South Africa
QC Technical Specialist
Biovac • Cape Town, Western Cape, South Africa
30+ days ago
Job descriptionAt least 3 years experience in vaccine / pharmaceutical / biotech manufacturing industry with QC Laboratory. At least 1 year experience at supervisory level is preferred. In-depth knowledge of Immunology / Biochemistry. Industry experience is preferred Exposure and understanding of scientific principles related to vaccine manufacturing and testing in the Biological Testing setting. Experience in quality and regulatory compliance within a cGMP facility. Experience in writing up quality documentation such as risk assessments user briefs gap assessments validation / verification protocols and reports. Experience in setting up new equipment in the QC laboratory within a cGMP facility. As well as on-boarding new methods onto equipment. Experience in setting up application software systems and manual processes to ensure Data Integrity compliance in the QC laboratory. Theoretical and practical experience in ELISA assays protein quantification assays endotoxin testing antigenicity testing and / or blotting assays. In-depth troubleshooting experience in immunological / molecular assays and equipment. Experience in having faced successful local and / or international quality audits (i.e. SAHPRA and WHO). Experience in technology transfer activities is important. 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 ELISA Protein Quantification Assays 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).
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 :
KEY DUTIES & RESPONSIBILITIES OF THE ROLE :
Application Deadline : 08 September 2025
If you do not receive a response from us within three weeks of submitting your application please understand that your application was not successful.
Disclaimer :
Dear Applicant we appreciate your interest in joining our organization. It is imperative for us that you understand how we handle your information. We are committed to ensuring the security and confidentiality of the information you provide. Your personal details will be collected for the sole purpose of the application process and will be used strictly for that purpose. By applying you acknowledge and consent to the collection use and protection of your personal information in accordance with our privacy policy. If you have any inquiries or concerns our Human Capital department is available to provide clarification. We look forward to reviewing your application.
Key Skills
Academics,Ale,Asset Management,Legal Operations,Art And Craft,Database Administration
Employment Type : Full Time
Experience : years
Vacancy : 1
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Technical Specialist • Cape Town, Western Cape, South Africa
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