Qc Supervisor: Projects

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 Supervisor: Projects to join a goal-oriented team.

**QUALIFICATIONS NEEDED**:

- Degree or diploma in Chemistry / Analytical Chemistry / Biochemistry/ Immunology / Biotechnology / 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 the 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.
- Planning and coordinating routine and non-routine laboratory testing related to projects (Chemistry, Micro & Biological).
- Co-ordinating executing Analytical Method Development (AMD) and Analytical Method Validation (AMV) activities for Chemistry test as per project schedule for analytical validation and/or analytical verification, Stability samples related to projects Chemistry, Micro & Biological testing.
- Compiling data trends, data analysis, and associated reports related to projects (Chemistry, Micro & 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 projects (Chemistry, Micro & Biological) testing.
- Ensuring that OOS/MDDs and OOT investigations are initiated and completed to the correct standard.
- Training and upskilling of analysts within the project team (Chemistry, Micro & Biological).
- Training project analyst (Chemistry, Micro & Biological) on theoretical aspects of Chemistry, Micro & Biological testing with a 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, Sterility, etc.).
- Selecting analytical test equipment for procurement and participating in equipment qualification e.g., review of qualification documents from a project (Chemistry, Micro & Biological) perspective.
- Assisting in writing and updating material and product specifications and test methods and standard operating procedures related to projects (Chemistry, Micro & Biological) testing.
- 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 projects (Chemistry, Micro & 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 projects (Chemistry, Micro & Biological) testing with new and upcoming technologies (e.g., LIMS, new hardware and software programs, new technologies), when necessary.
- Co-ordinating projects (Chemistry, Micro & Biological) Risk assessments in accordance with cGMP guidelines (e.g., ICH Q9, ICH Q10, etc).
- Assisting with the implementation of the site Containment and Control Strategy (CSS), with reference to projects (Chemistry, Micro & Biological) testing.

**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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