Implement and maintain the Quality Management System (QMS) in compliance with GMP cGMP and USFDA requirements
Manage Deviations CAPA Change Controls OOS/OOT investigations Risk Assessments and Document Control
Review & approve SOPs BMR BPR protocols
Required Candidate profile
Strong knowledge of QMS cGMP USFDA ICH guidelines Data Integrity & pharmaceutical regulatory requirements
Valuable analytical documentation investigation communication and problem-solving skills