Documentation Review & Control:
Review and approval of BMRs, BPRs, SOPs, and specifications.
Maintain and update controlled documents as per SOPs.
Quality Systems:
Handling deviations, change controls, CAPA, and out-of-specification (OOS) incidents.
Support in quality risk management and compliance audits.
GMP Compliance:
Ensure strict adherence to current Good Manufacturing Practices (cGMP).
Conduct internal audits and prepare for regulatory inspections (e.g., USFDA, WHO, MHRA).
Training:
Coordinate and conduct training sessions on quality systems and cGMP.
Maintain training records of all plant personnel.
Batch Release:
Support QA Manager in batch release procedures by ensuring documentation completeness and product compliance.
Vendor Qualification & Audits:
Assist in vendor qualification, audits, and evaluation of RM/PM suppliers.
Market Complaint Handling:
Investigate and document product complaints and implement corrective actions.
Environmental Monitoring (if applicable):
Coordinate with QC/Microbiology teams for environmental monitoring and validation protocols.