About the role
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.
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
- 5 years or more in 5 - 8 Years