- Authority to approve written procedures and other documents
- Develop Standard Operating Procedures and other quality related documents.
- Evaluation of batch manufacturing records and testing records
- Follow-up on preventive and corrective actions associated with deviations
- Interact with plant personnel to insure CGMP compliance.
- Prepare and maintain trend analysis
- Provides back up for other QA and plant site personnel as appropriate.
- The monitoring of compliance with the requirement of GMP
- Investigate complaints