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.
* Robust attention to detail to identify documentation errors and ensure data
integrity.
* Strong written and verbal communication skills for preparing repor

📌 Senior Executive, QMS (Ahmedabad)
🏢 Amneal
📍 Ahmedabad