Key Responsibilities
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.
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.
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.
GMP & Process Compliance
Conduct regular GMP and QA audits of manufacturing, filling, packing and warehouse areas.
Ensure compliance with approved SOPs and Positive Documentation Practices.
Report non-compliance and ensure corrective actions are implemented.
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.
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.
Complaints & Quality Issues
Support investigation of customer complaints, market complaints, returns and product defects.
Identify quality trends and initiate CAPA for recurring issues.
Audit & Compliance
Maintain audit-ready QA documentation.
Support internal, customer and regulatory audits.
Track audit observations and ensure timely closure.
Key Accountability