SCOPE / DIMENSIONS OF ROLE:
- To handle IPQA activities in shift independently.
- To ensure the documents (BMR/BPR/formats) issuance and initial review.
- To monitor the cGMP compliance at shop floor
RESPONSIBILITIES / ACCOUNTABILITIES:
- In-process checks during manufacturing and packaging process as per SOP (liquid and tablet section).
- Issuance of BMR/BPR to production as per SOP.
- Issuance of formats as per SOP.
- Line inspection of packaging activity as per the SOP. (liquid and tablet section)
- To conduct pack inspection.
- Verification and line clearance during dispensing. (Liquid and tablet section) to give Line clearance.
- Handling of shop floor compliance as per cGMP requirement.
- Timely reporting to the superiors regarding any abnormal result, non-conformance/ deviation observed during the in-process checks.
- Intermediate sample testing and approval.
- Review of the BMR and BPR.
- To ensure timely submission of samples to quality control.
- To collect the APQR data for APQR preparation.
- To assist in validation activities and SOP compliance.
- To monitor the process validation/qualification activities.
- Collection of retention samples.
- To investigate the shop floor deviation investigations.
- To monitor the CAPA effectiveness monitoring.
- To adhere to cGMP requirements.
- To adhere to data integrity policy.
- To improve the cGMP practices at shop floor.
- To update as per MHRA/MCC guidelines in working area.