Technical Specialist: Micro

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 Technical Specialist: Micro, Biological & Projects to join a goal-oriented team.

**QUALIFICATIONS NEEDED**:

- Degree or diploma in Biochemistry / Biological Sciences or equivalent.

**NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE**:

- At least 3 years of experience in the vaccine/pharmaceutical/biotech manufacturing industry with QC Laboratory,
- At least 3 years of experience within a QC Laboratory Chemistry Laboratory,
- 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.
- Providing technical support for the Micro, Environmental, and Biological department for the release of raw materials, production devices and packaging materials, intermediates, bulk and final products, Stability testing, and related investigations.
- Co-ordinating all analytical verification and analytical validation testing, for the Micro and Biological departments.
- Review laboratory raw data, including OOS/MDD and/or OOT results from internal and/or external testing related to Micro, Environmental & Biological.
- Ensuring that Micro, Environmental & Biological OOS/MDD, and/or OOT investigations are initiated and completed to the correct standard.
- Reviewing and approving documentation related to raw materials, production devices and packaging materials, intermediates, bulk and final products, and Stability testing, Sampling plans, Validation Plans, intermediates & final product specifications, test methods, and SOPs, from a Micro, Environmental & Biological perspective.
- 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 plans, protocols, and reports.
- Participating in the selection and procurement of analytical test equipment and participation in equipment qualification (e.g., review of qualification documents).
- Assisting with the completion of Capital Expenditure (CAPEX) documentation (e.g., equipment quotations, compiling URS, CAPEX forms, etc.) related to Micro, Environmental & Biological.
- Assisting with the control of Operational Expenditure (OPEX) for Micro, Environmental & Biological, when necessary.
- Adhering to Pharmaceutical Quality System (PQS) requirements (e.g., SOPs, CAPAs, Deviations, Risk Assessments, and Change Controls).
- Participating actively in quality audits and closing out gaps and findings.
- Participating actively in inspections, investigations, risk management, and quality review exercises.
- 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.
- Driving QC Projects actively in the Micro, Environmental & Biological teams as the main project member.
- Co-ordinating Data Integrity in the QC Laboratory with reference to Micro, Environmental & Biological along with new and upcoming technologies (e.g., LIMS, new hardware and software programs, new technologies), when necessary.
- Co-ordinating Micro, Environmental & Biological Risk assessments in accordance with cGMP guidelines (e.g., ICH Q9, ICH Q10, etc).

**Application Deadline: 15 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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