6 - 8 years
3 - 8 Lacs
Posted:1 day ago|
Platform:
Work from Office
Full Time
1 )Well versed in the analytical review of documents, which includes of those
from GLP section,
2) OOS, OOT, Events, Change control, CAPA related QMS handling
3) Column management, Standard handling, glassware management, chemical
management
4) Retention samples management and review of stability sample and study
management. To review of stability protocol/summary sheet
5) Computer system validation, calibration & qualification of instruments. Review
of audit trail from the computerized systems.
6) Ensure QC laboratory compliance at all times, participate in Lab check rounds.
7) Preparation & review of OOS/OOT/Events trending.
8) Review of analytical documents, chromatograms related to AMT/AMV
protocols and reports.
9) Preparation of SOPs
10) To review the Analytical reports in support of Batch release activities
1) To review and approve the batches with generation of Certificate of Analysis for
Finished Product
12) Review Analyst qualification data
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