Pharma Jobs at Amneal Pharmaceuticals | Apply Now for the Executive Role
Amneal Pharmaceuticals is hiring an Executive in CSV Quality in Ahmedabad, Gujarat. This role focuses on validating GxP systems, ensuring compliance with FDA, EU, and ICH guidelines, and supporting audits and inspections. Ideal for B-Pharmacy or M-Pharmacy graduates with advanced CSV and GAMP 5 expertise.
About Amneal:
Amneal is an equal opportunity employer committed to diversity and inclusion. The HR team drives organizational success through strategic people management, ensuring compliance with employment laws, and providing expert workforce management support.
Key responsibilities include performing system risk assessments to determine GxP impact, executing IQ, OQ, and PQ testing, and ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, MHRA, and ICH Q7/Q9 guidelines. The executive will support audits and inspections, maintain validation documentation, and participate in Change Control, CAPA, and Deviation management related to computerized systems.
Collaboration with IT, QA, Manufacturing, and Business teams is essential to validate ERP, LIMS, MES, CDS, QMS, and other GxP systems. The role also involves providing training on CSV processes and contributing to the transition from CSV to the Computer Software Assurance (CSA) approach.
Technical Skills Required:
- Advanced knowledge of the CSV lifecycle and GAMP 5 guidelines
- Proficiency in FDA 21 CFR Part 11 and EU Annex 11 compliance
- Expertise in writing validation documents (URS, FS, RA, IQ/OQ/PQ, VSR)
- Understanding of SDLC and risk-based validation
- Exposure to CSA approach
Qualifications:
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B-Pharmacy or M-Pharmacy
About The Team
The Human Resources team at Amneal plays a pivotal role in driving organizational success by managing people effectively and innovatively to meet both current and future business needs. They provide strategic input through their executive role in people management, ensuring informed decision-making at all levels, while also maintaining compliance with legal requirements and best-practice employment policies through their audit responsibilities.
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