- To ensure that all the activities carried out as per approved standard operating procedures and regulatory norms.
- To review the other department SOPs and ensuring the adherence to cGMP requirements
- To review Master Batch Manufacturing Records (MFRs, BMRs, ECRs & BPRs)
- To review the executed Batch Manufacturing Records, batch packing records & Equipment cleaning records.
- To participate in the investigations like OOS,OOT investigations, Deviation investigations etc.
- To prepare P/roduct Quality Review (PQR), Continuous process verification.
- To participate in the process validation & cleaning validation activities.
- To initiate and review the Change Controls.
- To review and monitor the corrective and preventive actions.
- To maintain the documents and relevant logbooks e.g. Deviation, Change control, OOS, OOT,CAPA etc.
- To monitor effectiveness of CAPA and change controls.
- Distribution and issuance of all GMP documents.
- To archive the master copies of production relevant master documents and master SOPs of all departments.
- To issue the BMR, BPR ,ECR & Analytical worksheets.
- To review analytical reports, Specifications, COA etc.
- Participate in all qualification and validation related activities.
- Responsible for handling qualification/requalification related activities.
- Responsible for handling Calibration and approval of certificates
- Responsible for dispatch activity
- To give line clearance.
- Support the customer and authority inspections and reply to various queries arising during the same.
- To carry out the work imparted by supervisor as and when required
- Handling TrackWise activity.
- Responsible to perform role as per EHS SOP during Emergency.
Preferred candidate profile
- Ready to shift to working location.
- Ready to work in shifts