Executive Job at Amneal | Pharma Graduates Apply Now
Amneal Pharmaceuticals is hiring for the position of Executive – CSV (Computer System Validation) in Ahmedabad, Gujarat. This Executive Job is ideal for pharmacy graduates with a strong background in validation, risk assessment, and compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines. The position involves ensuring GxP compliance across systems such as ERP, LIMS, MES, CDS, and QMS, while contributing to the company’s transition towards the Computer Software Assurance (CSA) approach.
- Job Title: Executive, CSV – Quality
- Location: Ahmedabad City, Gujarat, India
About Amneal
Amneal Pharmaceuticals is a U.S.-based integrated pharmaceutical company focused on the development, manufacturing, and distribution of high-quality generic and specialty medicines. Headquartered in Bridgewater, New Jersey, Amneal operates with a strong global footprint, including multiple manufacturing facilities in India and the U.S. The company’s diverse portfolio spans therapeutic areas such as central nervous system, oncology, cardiovascular, and anti-infective treatments. With a mission to make affordable medicines accessible worldwide, Amneal emphasizes innovation, compliance, and sustainability across all operations. Its commitment to research and development, coupled with advanced manufacturing capabilities, has made Amneal a trusted name in both generic and branded pharmaceuticals.
About the Team
The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.
Key roles that the Human Resources team performs
- Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.
- Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.
- Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.
- Consultancy Role: Provide expert advice to the organization and its managers on any aspect of workforce management and employee relations and performance.
- Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.
Amneal Job Responsibilities
- Review CSV deliverables: Validation Plan, User Requirements (URS), Functional Specifications (FS), Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, Validation Summary Reports.
- Perform system risk assessments to identify GxP impact and required validation.
- Review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing.
- Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, MHRA, ICH Q7/Q9 guidelines.
- Support audits and inspections (internal, regulatory, client).
- Collaborate with IT, QA, Manufacturing, and Business to ensure validation of ERP, LIMS, MES, CDS, QMS, and other GxP systems.
- Maintain validation documentation as per SOPs.
- Participate in Change Control, CAPA, and Deviation management related to computerized systems.
- Provide training and guidance on CSV processes and best practices.
- Contribute to transitioning from CSV to CSA (Computer Software Assurance) approach where applicable.
Technical Skills Required
- CSV lifecycle and GAMP 5 guidelines: Advanced
- 21 CFR Part 11 and Annex 11 compliance: Advanced
- Proficiency in writing validation documents (URS, FS, RA, IQ/OQ/PQ, VSR): Advanced
- SDLC (System Development Life Cycle) and risk-based validation: Advanced
- Exposure to Computer Software Assurance (CSA) approach: Advanced
Qualifications for the Amneal Job
- B-Pharmacy, M-Pharmacy
