Qc Supervisor Chemistry

2 weeks 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 meticulous QC Supervisor Chemistry to join a goal-oriented team.


**QUALIFICATIONS NEEDED**:

- Degree or diploma in Chemistry / Analytical Chemistry / Biochemistry or equivalent.

**NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE**:

- At least 3 years of experience in the vaccine/pharmaceutical/biotech manufacturing industry with QC Laboratory,
- At least 1-year experience at a 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).

**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 improve quality on-site.
- Co-ordinating Chemistry testing and release of starting materials (e.g., raw materials, production devices, and packaging materials) used in production processes, Stability testing, with analytical verification and analytical validation testing, when necessary.
- Review laboratory raw data, including OOS and or OOT results from internal and/or external testing related to Chemistry.
- Ensuring that OOS and OOT investigations are initiated and completed to the correct standard.
- Reviewing and approving documentation related to starting materials (e.g., raw materials, production devices, and packaging materials used in production processes), sampling plans, product specifications, intermediates, final product specifications, test methods, and SOPs.
- Liaising with suppliers on technical issues where applicable.
- Maintaining laboratory operations at cGMP standards to ensure quality, safety, and regulatory compliance.
- Co-ordinating the ordering and stock control with the Laboratory Support team.
- Compiling and reviewing analytical method validation/ verification protocols and reports.
- 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 closing out gaps and findings.
- Participating in inspections, investigations, risk management, and quality review exercises.
- Participating in project activities as a QC representative according to agreed project timelines.
- Participating in 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 Chemistry along with new and upcoming technologies (e.g., LIMS, new hardware and software programs, new technologies), when necessary.
- Co-ordinating Chemistry Risk assessments in accordance with cGMP guidelines (e.g., ICH Q9, ICH Q10, etc).

**Application Deadline: 11 August 2023**

**_Disclaimer: _**
- By submitting your CV and personal information, you agree that Biovac may utilise this information to conduct and complete our recruitment process, which entails distributing your information to all internal recruitment participants and service providers who forms part of the process._

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