Project Analyst Chemistry X4
2 weeks ago
**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: Chemistry to join a goal-oriented team.
**QUALIFICATIONS NEEDED**:
- Degree or diploma in Chemistry / Analytical Chemistry / Biochemistry or equivalent.
**NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE**:
- Experience in quality management systems within a cGMP facility.
- 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.
- Exposure to method development and method validation of pharmaceutical products,
- Experience in aseptic (sterile) manufacturing
**KEY DUTIES & RESPONSIBILITIES OF THE ROLE**:
- Independently implementing new Chemistry tests and new technologies independently.
- Independently executing Analytical Method Development (AMD) and Analytical Method Validation (AMV) activities for Chemistry tests as per project schedule.
- Independently testing routine and non-routine Chemistry samples from method development, method validation, and/or method verification.
- Independently testing routine and non-routine Chemistry testing (including utility testing, raw material, intermediate products, final product testing, and Stability testing).
- Participating in technology transfers from other vaccine manufacturers and other project activities, from a Chemistry perspective.
- Maintaining laboratory operations at cGMP standards to ensure quality, safety, and regulatory compliance.
- Stock control.
- Monitoring and maintaining Chemistry testing equipment.
- Drafting, updating, proofreading, and editing 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 analyst, when required.
- Actively involved with OOS and/or OOT investigation related to Chemistry 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.
**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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