Executive - Quality Control Micro Amneal Pharmaceuticals

2.0 - 6.0 years

0 Lacs

ahmedabad, gujarat

On-site

As a responsible team member in the pharmaceutical manufacturing process, your role involves the following key responsibilities: - Conduct line clearance activities before starting various operations such as dispensing, manufacturing, filling, inspection, sealing, labeling, and packing. - Perform process validation, cleaning validation/verification, hold time study, media fill, and routine batch sampling according to protocol/SOP. - Review executed Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs). - Perform in-process tests at different stages as per batch documents/SOP. - Review environmental monitoring and water trends. - Review different types of calibration certificates and planners. - Receive necessary resources for environmental monitoring from the microbiology lab and ensure proper handover of monitoring items back to the lab. - Monitor cGMP compliance on the shop floor. - Review various printouts such as CIP, SIP, autoclave, and filter integrity. - Maintain issuance/reconciliation records of items/media for environmental monitoring materials. - Conduct environmental monitoring of the manufacturing clean room area based on the defined schedule. - Participate in media fill simulation studies and qualification activities of the manufacturing area. - Monitor non-viable particles in the manufacturing clean room area and compressed air/nitrogen gas, as well as personnel monitoring. - Review Media Fill Completion Document (CD) and Visual Inspector Qualification Records. Additionally, you will need to manage environmental conditions like temperature, humidity, and light during stability testing to ensure accuracy and compliance. Qualifications required for this role include a Bachelor's (B.Sc.) or Master's (M.Sc.) degree. Please note that this job description pertains to a pharmaceutical manufacturing environment where attention to detail, adherence to protocols, and compliance with regulations are crucial for ensuring product quality and patient safety.,

Posted 1 day ago

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