To monitor and verification of IPQA activities.
To monitor manufacturing process for yield reconciliation.
To support validation plans for process validations/ cleaning validation and to support in review & approval of all validation documents and related activities.
Support in preparation, review and approval of documents such as master manufacturing records and review/authorization of executed batch documents.
Review and approval of Master Batch Manufacturing / Packing records.
To approve batch manufacturing record and batch packing record for release.
To implement corrective measures on the basis of self-Inspection, deviations, failure investigations.
To release the validation/commercial batches for sales/distribution.
Preparation of annual Product Review
Investigation of Market complaints, Incidence happening on Shop-floor,
Represent the company during external inspections.
Use of Statistical Tools (standard deviation, process capability etc.) and Problem solving tools for Root Cause analysis.
Reports the status of the quality levels of staff, systems and production activities and participates in improvement programs.
Participates in the evaluation of quality events, incidents and possible complaints and the follow-up activities in the GMP departments.
To participate as auditor for approval of RM/PM vendors and contract manufacturer.
Any other Jobs allotted by head of the department.
Responsible to perform the activity as appointed during absence of department head.
- Cleaning Validation
- Market Complaints
- Root Cause Analysis
- Problem Solving Tools
- Process Capability