Qc Analyst: Microbiology X6

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 Analyst: Microbiology to join a goal-oriented team.


**QUALIFICATIONS NEEDED**:

- Degree or diploma in Microbiology / Biotechnology / Biochemistry or equivalent.

**NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE**:

- At least 1- 3 years of experience in the vaccine/pharmaceutical/ biotech manufacturing industry with QC Laboratory.
- Demonstrated competency in laboratory skills, including documentation.
- Experience in quality and regulatory compliance within a cGMP facility.
- Experience in aseptic (sterile) manufacturing.
- Working knowledge of testing techniques in instruments in Microbiology.

**KEY DUTIES & RESPONSIBILITIES OF THE ROLE**:

- Implementing new tests and new technologies and participation in the qualification of related equipment related to Microbiology testing.
- Performing Microbiology testing, for analytical development, analytical verification, and analytical validation activities.
- Participating in technology transfers from other vaccine manufacturers and other project activities from a Microbiology perspective.
- Maintaining laboratory operations at cGMP standards to ensure quality, safety, and regulatory compliance.
- Controlling stock related to Microbiology.
- Monitoring equipment and maintenance of Microbiology equipment.
- Contributing to drafting, updating, proofreading, and editing of procedures related to Microbiology testing.
- Sampling of utilities, routine, and non-routine.
- Microbiology testing, routine, and non-routine (including utility testing, raw material, in-process, final product testing, and stability).
- Reviewing of laboratory raw data related to Microbiology testing.
- Compiling laboratory reports related to Microbiology testing.
- Completing trend analysis templates as laboratory results are obtained from a Microbiology perspective.
- Participate in departmental audits and implement corrective actions where relevant.
- Actively involved with OOS and/or OOT investigation related to Microbiology testing (internal or external testing) and ensuring that OOS and/or OOT investigations are completed on time, and to the correct standard.
- Ensure that DMS queries are attended to within a reasonable time as the System Owner and escalated to Laboratory Supervisors and management.
- Ensuring timely and effective communication by escalating quality issues to the appropriate levels of management, including DMS excursions.
- Assisting with the implementation of the Containment Control Strategy (CCS) for the site.

**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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