Advertisement
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:
Advertisement
- 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
Advertisement
