Quality

Key Responsibilities

*1. QMS & Documentation*

* Maintain and control SOPs, formats, specifications, master documents and QA records.

* Ensure proper document issuance, revision, retrieval and archival.

* Maintain *Deviation, CAPA, Change Control and Non-Conformance* records.

*2. Batch Documentation & Review*

* Review *BMR/BPR, IPQA records and QC reports* for completeness and compliance.

* Ensure all required checks and documents are completed before batch closure/release.

* Ensure deviations and discrepancies are properly addressed before release.

*3. Deviation, CAPA & Investigation*

* Record and investigate deviations and non-conformances.

* Perform/coordinate *Root Cause Analysis (RCA)*.

* Define CAPA with concerned departments and track timely closure.

* Check CAPA effectiveness and recurring quality issues.

*4. GMP & Process Compliance*

* Conduct regular GMP and QA audits of manufacturing, filling, packing and warehouse areas.

* Ensure compliance with approved SOPs and Good Documentation Practices.

* Report non-compliance and ensure corrective actions are implemented.

*5. IPQA Oversight*

* Review line-clearance and in-process quality records.

* Monitor recurring issues related to *shade, filling, leakage, components, packing and coding*.

* Coordinate corrective action with Production, IPQA and QC.

*6. Product & Packaging Quality*

* Ensure adherence to approved product, shade and packaging specifications.

* Coordinate with *QC, Production, NPD, Packaging and Warehouse* on quality issues.

* Review quality aspects of product/packaging changes.

*7. Complaints & Quality Issues*

* Support investigation of customer complaints, market complaints, returns and product defects.

* Identify quality trends and initiate CAPA for recurring issues.

*8. Audit & Compliance*

* Maintain audit-ready QA documentation.

* Support internal, customer and regulatory audits.

* Track audit observations and ensure timely closure.

Key Accountability

*QMS Compliance | Batch Documentation | GMP | Deviation Control | CAPA Closure | Audit Readiness | Product Quality*