Project Analyst: 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 Project Analyst: Micro & Biological 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 (e.g., Sterility testing /Environmental Monitoring/Endotoxin testing, etc).
- Exposure to method development and method validation of pharmaceutical products.

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

- Independently implementing new Micro & Biological tests and new technologies independently.
- Independently executing Analytical Method Development (AMD) and Analytical Method Validation (AMV) activities for Micro & Biological tests as per project schedule.
- Independently testing routine and non-routine Micro & Biological samples from method development, method validation, and/or method verification.
- Independently testing routine and non-routine samples of Utilities, Environmental Monitoring, Media Fills (Aseptic Process Simulations) & Microbiological identifications, Sterility testing, raw material, intermediate products, final product, and Stability testing.
- Participating in technology transfers from other vaccine manufacturers and other project activities, from a Micro & Biological perspective.
- Participating in implementing the site Containment, Control Strategy (CCS).
- Maintaining laboratory operations at cGMP standards to ensure quality, safety, and regulatory compliance.
- Stock control.
- Monitoring and maintaining Micro & Biological testing equipment.
- Drafting, updating, proofreading, and editing of procedures.
- Sampling of utilities, when necessary.
- Reviewing laboratory raw data, and compiling laboratory reports.
- Completing trend analysis templates as laboratory results are obtained.
- Participating in departmental audits and implementing corrective actions where relevant.
- Allocating tasks to analysts, when necessary.
- Coaching and training of analysts, when required.
- Actively involved with OOS/MDD and/or OOT investigation related to Micro & Biological testing (internal or external testing) and ensuring that OOS/MDD and/or OOT investigations are completed on time, and to the correct standard.
- Ensuring 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.

**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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