Qc Supervisor: Chemistry

7 days ago

Cape Town, South Africa Biovac Full time

**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 QC Supervisor: Chemistry to join a goal-oriented team. **QUALIFICATIONS NEEDED**: - Diploma or degree in Analytical Chemistry, Chemistry or equivalent. - Recognition is given to Prior Learning and practical experience. **NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE**: - 3+ years experience in a pharmaceutical QC laboratory or equivalent of which at least one year should be at Senior Analyst level. - 1 years Supervisory experience in pharmaceutical quality control or similar position would be an advantage. - Quality and regulatory compliance knowledge, i.e. SAHPRA and WHO would be an advantage. - Experience in having faced successful local and international quality audits would be an advantage. **KEY DUTIES & RESPONSIBILITIES OF THE ROLE**: - To ensure that the chemistry testing related activities are performed at the required quality levels (TBI, SAHPRA and WHO), within the agreed / budgeted time frame. - Ensure undisrupted, punctual and safe operation of staff and processes pertaining to raw material release, finished products, intermediates, utilities and stability testing. - Continually strive to deliver solutions through teamwork that ensures continuous improvement through innovative solutions. - Active guidance and coaching of staff within section. - Participating in project teams and supporting other relevant organisational departments. - Ensuring compliance in accordance with the Medicines and Related Substances Act 101 of 1965, Pharmacy Act 53 of 1974 and the organizations policies, procedures and other applicable laws. - Participation in quality audits and support to validation teams. - Effective implementation of quality systems. - Raw Material, intermediates, utility, stability and finished product testing. - Ensuring that all EHS related issues are in order and responsible for Safety Reps. - Ensure Change controls, Deviations, CAPAs and Risk Assessments are closed on time. - Investigate all OOS/OOT generated in the Chemistry section. **Data Integrity Compliance**: - Ensure all laboratory data is recorded, reviewed, and stored in accordance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available). - Promote a culture of data integrity by training staff on proper documentation practices and electronic data handling. - Monitor and audit data management systems to detect and prevent data manipulation, omissions, or unauthorized access. - Support implementation of secure, validated systems for electronic records and signatures in compliance with 21 CFR Part 11 and other applicable regulations **Application Deadline: 20 August 2025** **_ Disclaimer:_

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