Job title: AMD Chemistry Senior Scientist
Company: Biovac
Job description: 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 AMD Chemistry Senior Scientist to join a goal-oriented team.
QUALIFICATIONS NEEDED:
- Preferably PhD or MSc with at least 1-2 years experience in relevant discipline.
- or equivalent industry experience.
NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:
- 2 Years experience in vaccine/biotech/pharmaceutical industry or equivalent would be advantageous.
- 1 Year supervisory experience in product development or a cGMP environment.
- Exposure and understanding of scientific principles that govern the production of vaccines and/or biologicals.
- Quality & regulatory compliance knowledge, i.e. SAPHRA and WHO.
- GDP and IP management knowledge preferable.
- Experience in technology transfer would be advantageous.
- Knowledge of cGMP (SA, PIC, WHO) and GLP guidelines.
- Experience in having faced successfully local quality audits would be an advantage.
- Exposure to the development and commercialization of a pharmaceutical product.
KEY DUTIES & RESPONSIBILITIES OF THE ROLE:
- Laboratory Administration including Budgeting and Cost Control (Assists with group/unit budgeting, follows a cost-conscious culture within own department/group/unit.)
- Ensure services are delivered to all internal and/or external stakeholders as defined and as per agreed timelines.
- Risk and Anticipation Mitigation to ensure that all work done is in accordance with current standards/processes and assist Senior Scientist/Scientist to identify anticipated risks impacting group/unit/team.
- Follow cGMP guidelines and ensure all Change Controls/NCRs etc., are effectively managed to support QAs processes.
- Mitigate obvious risks on site and submit job cards to address facility issues/risks as per the process set by Engineering.
- Close all actions assigned to self/staff member as per EHS committee agreed deadlines.
- Responsible for providing assistance, guidance, problem solving or input to the operational departments as required and agreed.
- Responsible and accountable for the generation of applicable documentation in accordance with current scientific, GMP and GDP guidelines.
- Responsible for analytical method development (chemical).
- Responsible for experimental design, planning, execution, problem solving and recording.
- Accountable for specified deliverables within projects according to agreed timelines.
- Assist with technology transfers from development to manufacturing (including manufacture of material to be used in clinical trials).
- Driving Innovation and Continuous Improvement.
- Driving Quality Risk Management.
- Managing Deviations, Change Controls, CAPAs.
- Quality Objectives: Drive the quality objectives.
- Communication: Ensure timely and effective communication. Escalate quality issues to the appropriate levels of management.
Application Deadline: 30 September 2024
Expected salary:
Location: Cape Town, Western Cape
Job posting date: Sat, 07 Sep 2024 22:21:08 GMT
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