Assistant Manager

1 month ago


india Zentiva Group, a.s. Full time

Description

: Handling of deviation, change control, market complaints and CAPA. Responsible for conducting the investigation for OOS, OOT, complaints & deviations. Trending of the OOS / OOT Change Controls, complaints, Deviations and CAPAs. Responsible for supplier Quality assurance activities Preparation of APQR (Annual Product Quality Review) & evaluation of Process capability analysis. Responsible for routine Manufacturing compliances & in- process activities. Review of process validation protocols and reports. Review of cleaning validation protocols and reports. Review of equipment qualification protocols and reports. Review of Batch manufacturing records (BMRs), Analytical testing records and related documentation. Responsible for batch Release / rejection in SAP/LIMS. Preparation, Review and Issuance of SOPs and formats. Handling of LIMS for batch release and rejection. Should have experience with facing regulatory audits such as USFDA, MHRA etc. Knowledge of GMP and regulatory requirements. Excellent written and spoken communication skills.
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