Job Purpose
To maintain an effective pharmaceutical Quality Assurance system and independently monitor compliance of manufacturing, documentation, personnel, premises, equipment and products with GMP and approved quality procedures.
Key Responsibilities
· Review and monitor Batch Manufacturing Records, Batch Packaging Records, cleaning records, environmental records and other GMP documentation.
· Review and control SOPs, forms, specifications and other controlled quality documents in coordination with Document Control.
· Conduct routine GMP inspections and in-process quality compliance checks.
· Review, document and follow up deviations, non-conformances, CAPA, change controls and quality-related investigations.
· Participate in qualification, validation, calibration, internal audits and supplier qualification activities as required.
· Monitor implementation and effectiveness of CAPA and change controls.
· Ensure proper traceability, data integrity and good documentation practices throughout the quality system.
· Coordinate with QC regarding laboratory results, OOS/OOT investigations and product quality trends.
· Support product complaints, recalls, returns and other quality-related investigations.
· Participate in training programs related to GMP, documentation, hygiene, quality systems and data integrity.
· Escalate critical quality issues to management without undue influence from production targets.
· Maintain QA records and prepare reports for management and regulatory inspections.