Job title : Laboratory Validation Chemist
Job Location : Gauteng,
Deadline : October 25, 2024
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Job Purpose
- The incumbent is responsible for planning, drafting protocols, execution and final reporting approval of Analytical Method validation (AMV), Analytical Method transfer (AMT) and Process Validation (PV) / special request (non-routine) samples in accordance with procedure.
Key Accountabilities (1/5)
- Provides support to quality control and manufacturing for resolution of analytical and quality related problems
- Works on Tech transfer projects.
- Responsible for ensuring GAP analysis and risk assessments are submitted on time for tech transfer products
- Drafts all protocols related to Analytical method development, method transfer, cleaning validation methods and method verification.
- Prepares tracker for AMD, AMV and AMT to be performed and report on progress on Monthly basis.
- Execute all protocols as per plan and tracker.
- Ensure staff is trained on the procedures.
- Logs CAPA, Deviations and Change controls and ensure they closed within stipulated time frame.
- Implements activities to prevent recurring of OOS and OOT attributed to QC function
- Trouble shooting
- Responsible for ensuring the integrity of all data and documentation reported from the Chemistry Laboratory.
- Reviews all source data for conformance to applicable specifications.
- Facilitates data or documentation corrections with analysts to ensure all records are complete and appropriate references are made.
- Ensures investigations are assigned, completed and referenced for data or documentation, as appropriate, prior to release of Chemistry data.
- Interacts routinely with departments such as Production, RA, R&D, QA Validation team
- Assist in performing Quality Assurance audits on laboratory areas to ensure cGMP compliance.
- Assist in the investigation and review of deviation reports and OOS reports to assure complete and compliant source data.
- Assist in training and mentoring junior analysts on the interpretation of data and use of electronic data systems.
Key Interactions
- All internal departments (Engineering, Quality Control, SHERQ, Finance, Supply Chain, Admin
Education Qualification
- National Diploma / BTech Degree and or B.Sc. in Analytical Chemistry/Biotechnology
Relevant Work Experience
- 4-7 years in a laboratory environment.
How to Apply for this Offer
Interested and Qualified candidates should Click here to Apply Now
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