Educational Qualifications Preferred - B. Pharm/ M.Sc
Experience - 01 - 03 years of experience in Pharmaceutical industry.
Job Responsibilities
- To review of analytical data of FG, RM, Stability study, Validations, water testing, Miscellaneous material and CSV etc. as per approved specification and qualification documents.
- To ensure the GLP practices in the OC Lab and to highlight the non conformances with the respect to procedures, Specifications, SOP's GLP etc. on day today basis Numbers of critical/ major nonconformance noticed.
- Monitor on line analytical data, Logbooks completion & review of documents like calibration records in the concerned departments.
- Review the investigation activity performed for the OOS/OOT, Incidence, Deviation and change control related to QC.
- Perform periodic review activity for CDS instrument and non-CDS instruments.
- To review the protocols/reports and monitoring the activity of Technology Transfer/ AMW/ Partial AMV / Qualification/ Stability Study, Hold time study protocols, calibration of QC Instruments/software, stability Trend Data & Reports as initiated by QC departments.