- Ensure compliance to cGMP for all operational activities.
- Monitor the formulated products against stipulated conditions mentioned in the Batch production record.
- Conduct certificate of batch production records for compliance and stage wise completion.
- Conduct line clearance during manufacturing and the packing activities.
- Conduct sampling activities during the manufacturing and the packing activities.
- Conduct qualification, PPV, PM and calibration of in-process instruments as per schedule.
- Swab and Rinse sampling activity for cleaning validation and verification studies.
- Initiate Deviation, Change Control and Investigations.
- Provide support to conduct investigations related to deviation, CAPA, OOS, OOT, and Market complaint handling.
- Issuance of Batch production records.
- Review & Verification of Bin for Documents / Labels Destruction as per SOP.
