Job Description
Job Location: Hyderabad
Department Details
Quality Control - Microbiology
Role Summary
Team Lead - Compliance and Reviewer
Key Responsibilities
Handling of change controls in Microbiology laboratory.Review of equipment and instruments usage logbooks.Preparation and review of Evaluation and establishment of microbiological specifications reports.Review of Microbial Limit Test reports.Review of Bacterial Endotoxin Testing reports.Preparation and review of standard operation procedure.Review of disinfectant preparation and cleaning records.Review of daily monitoring records.Preparation and Review of calibration, PM schedulesReview of samples in LIMS.Preparation and Review of reports for Evaluation and establishment of microbiological specifications for active pharmaceutical ingredients.Preparation of product specifications and STP's.Preparation and review of method transfer protocols, reports.Preparation and review of schedules, sampling schemes planner.Preparation and review of investigation reports, such as incidents, OOT, OOS, Deviations and any nonconformance. Qualifications & Experience
Qualification: MSc (Microbiology / Bio-Technology)
Experience: 10 to 12 years
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