Executive, QA Validation
Amneal Career Sites
Executive, QA Validation
About this role
Description:
Prepare and review qualification protocols and reports for equipment, utilities, and systems (DQ, IQ, OQ, PQ, as applicable).
Coordinate and monitor qualification activities with Engineering, Production, and Validation teams.
Ensure qualification documentation complies with GMP and regulatory requirements. Maintain qualification schedules and ensure periodic requalification is completed on time.
- Conduct quality risk assessments using tools such as FMEA, HACCP, or risk matrices.
- Identify potential quality risks and recommend appropriate mitigation strategies.
Ensure risk management documentation is maintained and periodically reviewed.
Draft, review, revise, and maintain Standard Operating Procedures (SOPs), work instructions, protocols, and quality documents.
Ensure document control procedures are followed throughout the document lifecycle.
Coordinate periodic review of controlled documents.
Provide training on new or revised SOPs and maintain training records.
- Identify opportunities for process improvement and quality enhancement.
- Support implementation of quality metrics and trend analysis.
Participate in cross-functional quality improvement projects.
- Develop and review process validation protocols, reports, and validation master plans.
- Coordinate execution of process validation activities with cross-functional teams.
- Evaluate validation data and ensure processes consistently meet predefined acceptance criteria.
Support cleaning validation, analytical method validation, and computerized system validation where applicable.
Additional Skills :
- Knowledge of GAMP 5 and 21 CFR Part 11.
- Strong Understanding of ALCOA+ principles.
- Performing risk assessments using tools like FMEA, HACCP, and risk matrices.
- Hands-on experience with IQ, OQ, PQ, and requalification of manufacturing and laboratory equipment.
- Strong Project Management Skills
Education:
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
- 2 years or more in 2 - 5 Years
Frequently Asked Questions
Is the salary disclosed for the Executive, QA Validation position at Amneal Career Sites?
The salary for this Executive, QA Validation 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 Executive, QA Validation position at Amneal Career Sites located?
This Executive, QA Validation 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 Executive, QA Validation role at Amneal Career Sites full-time or part-time?
This is listed as a Full time position. It is posted as a Executive, QA Validation role at Amneal Career Sites.
How do I apply for the Executive, QA Validation 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 Executive, QA Validation job at Amneal Career Sites posted?
This Executive, QA Validation position at Amneal Career Sites was posted on Aug 24, 2026. Apply as soon as possible — early applications are often reviewed first.
Executive, QA Validation
Amneal Career Sites
You'll be redirected to Amneal Career Sites's official application page on oraclecloud.