Are you a B.Pharm or M.Pharm professional passionate about Computer System Validation (CSV) and pharmaceutical quality compliance?
Here’s your chance to advance your career with Amneal Pharmaceuticals, a global leader in healthcare innovation.

As an Executive, CSV – Quality, you’ll play a pivotal role in ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ICH Q7/Q9 guidelines while validating critical GxP systems such as ERP, LIMS, QMS, and MES.

🧩 Key Responsibilities

• Review CSV deliverables: Validation Plan, URS, FS, RA, IQ/OQ/PQ, Traceability Matrices, VSR
• Conduct system risk assessments to evaluate GxP impact and validation requirements
• Ensure alignment with regulatory guidelines: FDA 21 CFR Part 11, EU Annex 11, MHRA, and ICH Q7/Q9
• Support internal, regulatory, and client audits and inspections
• Collaborate with IT, QA, Manufacturing, and Business functions for system validation
• Maintain validation documentation per SOPs
• Manage Change Control, CAPA, and Deviation processes related to computerized systems
• Contribute to transitioning from CSV to CSA (Computer Software Assurance)
• Provide training and guidance on CSV best practices

🎓 Qualifications and Skills

Educational Qualification:

• B.Pharmacy or M.Pharmacy

Technical Expertise:

• Advanced understanding of CSV lifecycle and GAMP 5 guidelines
• Proficient in 21 CFR Part 11 and Annex 11 compliance
• Expertise in creating validation documents (URS, FS, IQ/OQ/PQ, VSR)
• Strong command of SDLC and risk-based validation
• Exposure to CSA (Computer Software Assurance) approach

💼 Why Join Amneal?

• Work with a globally recognized pharmaceutical organization
• Engage in cutting-edge quality and compliance projects
• Be part of a diverse, inclusive, and growth-oriented environment
• Opportunity to contribute to next-gen CSV to CSA transformation

📍 Job Details

• Position: Executive – CSV (Quality)
• Location: Shapath-V, Near Hotel Crown Plaza, Ahmedabad, Gujarat, India – 380015
• Department: Quality Assurance
• Job Type: Full-time
• Application Deadline: 15 November 2025
• Expected Salary Range: ₹4.8 – ₹7.5 LPA (based on experience)
• Posting Date: 06 November 2025

📝 How to Apply

Application Link