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24 × 7 audit readiness.
Exposure in Wet Chemistry.
Responsible to works in different shifts.
Perform the raw material analysis & wet lab activity by using the technique (KF, pH, KFC, UV, FTIR, SOR, Oven, Auto titrator, Polari meter & TLC) etc.
Sampling of Raw material / FG / intermediates / cleaning samples based on requirement and result entry in analytical sheet, QA form, LIMS and online documentation as per data integrity norms.
Perform analytical test according to the monograph and SOP.
Follow up the housekeeping, cGMP, GLP and Safety Guideline in laboratory.
Participation in internal, external, regulatory audits.
Ensure 100% participation in training’s against CAPA’s.
Responsible for initiation and investigation on LIR, OOS, OOT & boarder line results and reporting them to the in-charge.
Determining team priorities in accordance with the plant’s needs, while coordinating with the team leader /Manger.
Responsible for calibration and verification of instruments.
Maintaining of reserved samples room and chambers.
Must be ensured sampled, approved, and rejected labels timely as required.
Responsible to maintain the stock record of chemicals and reconciliation of standards.
Any other job assigned by the Manger -QC Manger or group leader-QC
M.Sc. / B.Sc. Chemistry
5+ Years (Pharma API Industry)
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