Senior Executive, QMS

Amneal Career Sites
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📍 Ahmedabad City, Gujarat, IndiaFull time

About this 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.
Education:
  • B. Pharm B. Pharm - Required
  • M. Pharm M. Pharm - Preferred
Experience:
  • 5 years or more in 5 - 8 Years
Specialized Knowledge: Licenses:

Frequently Asked Questions

Is the salary disclosed for the Senior Executive, QMS position at Amneal Career Sites?
The salary for this Senior Executive, QMS role at Amneal Career Sites is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Senior Executive, QMS position at Amneal Career Sites located?
This Senior Executive, QMS role at Amneal Career Sites is based in Ahmedabad City, Gujarat, India. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Senior Executive, QMS role at Amneal Career Sites full-time or part-time?
This is listed as a Full time position. It is posted as a Senior Executive, QMS role at Amneal Career Sites.
How do I apply for the Senior Executive, QMS position at Amneal Career Sites?
Click the "Apply Now" button on this page. You will be redirected to Amneal Career Sites's official application portal hosted on oraclecloud where you can submit your application directly.
When was the Senior Executive, QMS job at Amneal Career Sites posted?
This Senior Executive, QMS position at Amneal Career Sites was posted on Aug 24, 2026. Apply as soon as possible — early applications are often reviewed first.
Senior Executive, QMS
Amneal Career Sites
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