Asst. Manager
1 week ago
Role & responsibilities
- To review of monthly stability sample scheduler, stability protocol and stability summary.
- To review of list of finished product reserve sample, reserve sample record, verify physical observation of reserve sample on timely basis and issuance of reserve sample on the basis of requirement.
- Review of complete QC documents before batch release.
- Review of all instrument calibration/qualification of QC and all liquid and solid chemicals & water Analysis.
- Specification, STP and TDS implementation and review of all logbooks, SOP'S & STP's.
- Review of reference standards & working standards and analytical method validation.
- Chromatogram and audit trail review.
- Review of QMS documents (Incidence/Deviation/Change control/OOS/OOT/OOC/CAPA).
- Microbiological review (Calibration/Documents/Instruments/SOP).
- Review of Physical availability of glass wares/utensils.
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