Key Responsibilities - Coordinate and compile Annual Product Quality Reviews for all commercial products in accordance with regulatory requirements e g EU GMP Part I ICH Q7 ICH Q10 - Collect and trend data from multiple departments Production QC QA Engineering and Regulatory Affairs - Analyze product quality trends deviations complaints out-of-specification OOS results and CAPAs - Collaborate with cross-functional teams to gather accurate and complete information - Prepare comprehensive APQR reports highlighting key findings trends and recommendations - Ensure timely completion of APQRs as per the internal schedule and regulatory expectations - Identify potential areas for process improvement or quality enhancement - Support audits and inspections regulatory internal customer by presenting APQRs and related data - Maintain up-to-date knowledge of regulatory guidelines and industry best practices Qualifications and Experience Education Bachelor s or Master s degree in Pharmacy Chemistry Biotechnology or related scientific discipline Experience - 2-5 years of experience in Quality Assurance within a regulated industry preferably pharmaceuticals or biotech - Hands-on experience with APQR preparation and data analysis - Strong knowledge of cGMP ICH guidelines and regulatory requirements - Proficiency in Microsoft Office especially Excel Word and PowerPoint - Experience with electronic documentation systems e g TrackWise MasterControl is an advantage Job Type Full time Pay 30 000 00 - 40 000 00 per month Schedule Day shift Education Bachelor s Preferred Experience Quality Assurance 2 years Preferred regulated industry 1 year Preferred APQR preparation 1 year Preferred data analysis 1 year Preferred cGMP ICH guidelines 2 years Preferred Pharma Industry 2 years Preferred Work Location In person