Position : Manager/ Sr. Manager Quality Control
Location : Tarapur
Qualification: B Sc / M Sc
Experience : 18 - 22 years
Key Responsibilities:
- Responsible for monitor all cGMP and GLP activities in the Laboratory.
- Responsible for daily planning of QC activity. Review of analytical raw data, Approval and reject of Raw material, Finished product ,Packing material, Stability sample.
- To ensure sampling and all testing of raw material, Inprocess, Finished product, process validation & hold time analysis , Stability sample, packing material as per procedure.
- To review of Specification ,Test procedure and SOP.
- Review of Analytical method transfer and process validation documents.
- Ensure Handling & timely closing incidents, Deviations ,Change control.
- Investigation of OOS, OOT ,Market complaints & closing timely.
- Responsible for Working standard, reference standard manaqement.l-PLc Column management
- To ensure instruments are periodically calibrated and maintenance of instruments as per schedule.
- To handle all internal, external and regulatory audit.
- To monitor sample for contract laboratories analysis
- To review and approval of calibration record of analytical instruments.