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4.0 - 8.0 years
5 - 9 Lacs
Boisar
Work from Office
Monitor all in-process manufacturing and packaging activities on the shop floor. Perform line clearance before manufacturing/packaging starts. Verify batch records and ensure adherence to SOPs and BMR/BPR entries. Check critical control points and parameters during manufacturing. Review batch manufacturing records (BMR), batch packaging records (BPR), and logbooks in real time. Ensure timely and accurate documentation of in-process observations. Escalate any deviation or non-conformance observed during the process. Ensure compliance with cGMP, GDP, and regulatory requirements. Assist in handling deviations, change controls, and CAPAs. Participate in internal audits and regulatory inspections. Verify the status and calibration of equipment before use. Ensure proper labeling, handling, and storage of materials.
Posted 1 month ago
0.0 - 5.0 years
3 - 6 Lacs
Pune
Work from Office
Job Description: We are looking for a dynamic and experienced Production Officer to oversee day-to-day production activities in our API manufacturing plant . The ideal candidate should have a strong understanding of batch processing, GMP compliance, equipment operation , and regulatory documentation . Key Roles & Responsibilities: Execute production activities as per batch manufacturing record (BMR) and standard operating procedures (SOPs) . Handle and operate plant equipment such as reactors, centrifuges, ANFD, FBD, dryers , etc. Ensure timely charging and discharging of materials and maintain strict compliance with process parameters . Perform in-process checks and report any deviation or abnormalities. Maintain online documentation including logbooks, equipment usage records, cleaning records, and BMR entries. Monitor critical process parameters and ensure compliance with cGMP , safety , and EHS standards . Coordinate with QA/QC for line clearance, sampling, and process validations . Ensure cleaning and sanitization of production areas and equipment as per defined protocols. Support in process validation, scale-up batches, and technology transfer when required. Follow all safety protocols , including proper usage of PPE and handling of hazardous chemicals. Report incidents, deviations, and OOS/OOT results to the production supervisor or department head. Ensure timely completion of production targets with quality and compliance focus.
Posted 2 months ago
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