Quality Assurance & Compliance
Ensure compliance with GMP, GLP, and regulatory guidelines.
Monitor manufacturing, packaging, and testing activities for adherence to approved procedures.
Review and approve Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR).
Documentation & Record Control
Prepare, review, and maintain SOPs (Standard Operating Procedures).
Handle document control system — issuance, revision, archival.
Ensure all quality-related documentation is accurate and up to date.
Deviation & Change Control
Investigate deviations, OOS (Out of Specification), and incidents.
Initiate and track CAPA (Corrective and Preventive Actions).
Manage change control processes and risk assessments.
Validation & Qualification
Support qualification activities (IQ, OQ, PQ).
Participate in process validation, cleaning validation, and equipment validation.
Audit & Inspection
Support internal and external audits (regulatory, customer audits).
Prepare audit responses and ensure closure of observations.
Ensure readiness for inspections by regulatory authorities.
Quality Systems
Monitor quality metrics and trends.
Maintain product release procedures and ensure timely release.
Handle complaints, recalls, and quality risk management.