- Review manufacturing and packaging documentation
- Retrieve and review batch records as per cGDP, cGMP, CPC SOPs, and FDA guidelines
- Perform batch data entry for APR and process validation
- Prepare Annual Product Review (APR), BPR / Product Quality Review (PQR) reports
- Review process validation reports Review and approve vendor audit documentation
- Coordinate with suppliers for quality agreements
- Maintain audit certifications and compliance records
Preferred candidate profile Solid understanding of cGMP, US FDA, and EU regulatory requirements
Knowledge of manufacturing & packaging processes
Proficiency in MS Office (Word, Excel, data analysis)
Excellent documentation, communication, and organizational skills
High attention to detail and ability to work in a fast paced environment