Senior Officer, QA Environment Monitoring Amneal Pharmaceuticals

2.0 - 6.0 years

0 Lacs

ahmedabad, gujarat

On-site

You will be responsible for conducting line clearance activities before starting various operations such as dispensing, manufacturing, filling, inspection, sealing, labeling, and packing. Additionally, you will perform environment monitoring activities and ensure compliance with cGMP at the shop floor. Your role will involve process validation, cleaning validation/verification, hold time study, media fill, routine batch sampling, and in-process testing at different stages according to batch documents and SOPs. You will review executed BMRs, BPRs, environment monitoring data, water trends, printouts (CIP, SIP, autoclave, filter integrity), and different types of planner and calibration certificates. Furthermore, you will receive necessary resources for environmental monitoring from the microbiology lab, conduct environmental monitoring in the manufacturing clean room area as scheduled, and participate in media fill simulation studies and qualification activities of the manufacturing area. You will also be responsible for non-viable particle monitoring, compressed air/nitrogen gas monitoring, personnel monitoring, and reviewing Media fill CD and Visual inspector qualification records. Qualifications: - Education: B.Sc./M.Sc. in Microbiology - Total Experience: 2-4 years of experience in Environmental Monitoring for a sterile manufacturing plant Please note that candidates applying for internal positions must have completed at least 2 years in their current role.,

Posted 2 weeks ago

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