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.
- Robust 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:

📌 Senior Executive, QMS (India)
🏢 Amneal Pharmaceuticals
📍 India