Job Description
- Prepare test solutions for performing various laboratory tests
- To execute analytical testing to support commercial drug substance and drug product release, in process and stability sample testing.
- Maintain operational readiness and GMP compliance of the lab.
- Assist training of analysts in proper execution of GMP procedures. Planning execution of analytical method validation studies in compliance with current regulatory requirements and industry guidelines.
- Testing: Perform sample testing and analysis for release, stability, non-routine and in process samples within established turn.
- Work within QC to maintain efficient compliant laboratory (including but not limited to instruments, documentation, SOPs, etc).
- Compliance: Prepare and execute Quality System documents according to established procedures.
- Identify and recognize procedural deviations and identify corrective actions, and communicate immediately with supervisor.
- Keep update all related SOPs on regular basis.
- Maintained and update all related documents, files & records.
- To Assist in refinement of analytical methods as required. Inspects and analysis incoming raw material and production batches.
Job Specification
having knowledge of conventional analytical technique and well versed with modern instrumental techniques.