Officer - Quality Assurance

Role & responsibilities

• 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

Strong 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