Role & responsibilities
1) Well versed in the analytical review of documents, which includes of those from GLP section, OOS, OOT, Events, Column management, Standard handling, pharmacopeia, retention samples, stability management & review of stability protocol/summary sheet, computer system validation, calibration & qualification of instruments.
2) Review of audit trail from the computerized systems.
3) Ensure QC laboratory compliance at all times.
4) Preparation & review of OOS/OOT/Events trending.
5) Review of analytical documents, chromatograms, AMT/AMV protocols and reports.
6) Review of specification & STP.
7) Preparation of SOPs
7) To review the Analytical reports in support of Batch release activities
8) To review and approve the batches with generation of Certificate of Analysis for Finished Product
10) Review Analyst qualification data
11) Monitor control sample management.
12) Check rounds of lab and participate in internal audits
13) Leading the group independently in the absence of Manager and planning the activities
Preferred candidate profile Candidate should have good experience in Lab QA, Method validation, Method transfers Qualification of instruments CSV with 21CFR part 11. Interested candidates may apply on [email protected]
