❖ Process validation & Cleaning Validation: Review of Process validation & Cleaning validation Protocols and Reports for various products and product changeovers. And monitoring the validation batches.
❖ Annual Product Quality Review: Preparation and review of Annual product quality review of various.
❖ Customer complaints & Returns: Handling of Return goods and customer complaints investigations.
❖ Change Controls: Handling and monitoring of change control systems for all changes with respect to process, facility or procedures.
❖ Deviations: Handling and monitoring of deviations with respect to shop floor activities and documentation.
❖ IPQA Activities: Day to day online monitoring of manufacturing blocks & warehouse.
Identification of incidents and evaluation of impact.
➢ Online verification of BPRs and control records.
➢ Line clearance for cleaning and operations.
➢ Review and monitoring of all plant related log books as per SOP and cGMP practices.
❖ Review of Batch Production and Control Records:
Review of Master Batch production and control records in line with the technical package & Review of executed BPCR and related documentation with respect to shop floor and QMS.
❖ Transport Validation: Review of transport validation protocols and report various products.
❖ Dispatch Activity: Review and release of dispatch orders for various customers against to specification and purchase orders.
❖ Document Control: Monitoring for the controlling, issue and retrieval of the all documents. Document archival and proper arrangement with identification label.
❖ Other activities:
➢ Batch release and approved in ERP system.
➢ Supporting of Mock recall.
➢ Handling of issuance and retrieval of Batch Production and Control Record through manual as well as electronic system (DIMS software and Agile software).
➢ Supporting of Vendor Qualification to approval of starting material, Raw material.
➢ Supporting to HOD/ In-charge during Customer Audits and regulatory inspections.