Qc Supervisor Laboratory Support

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 Laboratory Support to join a goal-oriented team.


**QUALIFICATIONS NEEDED**:

- Degree or diploma in Chemistry/Analytical Chemistry/ Microbiology / 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 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 all cleaning activities of Laboratory (graded and non-graded) areas within QC Laboratory and related areas (e.g., Glassware cleaning (volumetric and non-volumetric), autoclaving of glassware and/or consumable devices, etc.).
- Co-ordinating all administration activities for QC Laboratory (e.g., sample receipt, sample tracking, processing of laboratory documents and/or reports, archiving, etc.).
- Co-ordinating all the Inventory management of all laboratory consumables/reagents/reference standards/cultures.
- Training and competency assessments of Laboratory Support staff to the necessary standards.
- Co-ordinating the updating of starting material specifications, test methods, product specifications, test methods, and standard operating procedures to the latest pharmacopeial requirements.
- Co-ordinating all waste removal from QC Laboratory correctly according to approved quality and safety procedures.
- Maintaining laboratory operations at GMP standards to ensure quality, safety, and regulatory compliance.
- Identify/participate in inspections, investigations, risk management, and quality review exercises.
- Co-ordinating analytical method transfers from technology transfer to Biovac and their implementation in the QC laboratory related to Laboratory Support.
- Assisting other departments with closing OOS/MDD and OOT investigations to the correct standard within the required due dates, when necessary.
- Participate 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.
- 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 Microbiological & Environmental Monitoring testing with new and upcoming technologies (e.g., LIMS, new hardware and software programs, new technologies), when necessary.
- Co-ordinating Laboratory Support 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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