Description: • Independently conduct and prepare investigation reports for Product Quality Complaints, Unplanned Deviations, OOS, OOT, and OOAL events, ensuring timely closure and regulatory compliance. • Perform root cause analysis using appropriate tools (5-Why, Fishbone, Risk Assessment, etc.) and recommend effective corrective and preventive actions (CAPA). • Initiate, review, track, and verify CAPA implementation and effectiveness within established timelines. • Review and coordinate Change Controls related to processes, equipment, facilities, systems, materials, and documentation, including quality and regulatory impact assessments. • Analyze and prepare annual trend reports for Unplanned Deviations, Complaints, CAPAs, OOS, OOT, and OOAL events to identify recurring issues and drive continuous improvement. • Prepare Quality Metrics, Management Review reports, and periodic trend analyses for site leadership. • Maintain QMS records in compliance with cGMP, Data Integrity (ALCOA+), and company procedures. • Support internal audits, customer audits, and regulatory inspections. • Assist in the development, review, and revision of SOPs and other quality system documents. • Collaborate with Manufacturing, Quality Control, Engineering, Validation, and other cross-functional teams to resolve quality issues. • Support inspection readiness initiatives and promote continuous improvement of Quality Management Systems. • Ensure all activities are performed in compliance with applicable cGMP, FDA, ICH, company policies, and Health & Safety requirements. Additional Skills • Strong understanding of QMS principles and compliance. • Knowledge of GMP, cGMP, GLP, GDP, and regulatory requirements from agencies such as the U.S. Food and Drug Administration, European Medicines Agency, and World Health Organization. • Strong attention to detail to identify documentation errors and ensure data integrity. • Strong written and verbal communication skills for preparing reports, leading discussions, and driving quality initiatives. Education: • B. Pharm B. Pharm - Required • M. Pharm M. Pharm - Preferred Experience: • 5 years or more in 5 - 8 Years Specialized Knowledge: Licenses: