About the role
Description JOB 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 QUALIFICATIONS
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
Experience:
- 5 years or more in 5 - 8 Years
Specialized Knowledge: Licenses:
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