Job Profile:

❖ 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.