Senior Consultant | CSV | Hyderabad | SAP

Key skills required

- Should have at least 4 years of experience in quality assurance and/or computerized system validation processes in a regulated workplace in life sciences and healthcare (LSHC) industry.
- Knowledge of and experience with regulatory requirements (e.g. GMP, 21 CFR Part 11, 21 CFR Part 820, EU Annex 11 etc..)
- Participate as a Validation Subject Matter Expert to support the development of business requirements documentation, technical designs, test strategy and plans, etc.
- Responsible to set up the validation strategy to ensure agility & speed in delivery
- Minimum of 5 years of relevant work experience as a Computer System Validation Professional, including hands-on experience with domain systems (Enterprise Level Application i.e., ERP, MRP, QMS, LIMS, etc.)



in support of global business operations
- Should be able to defined and execute end to end validation activities for IT projects and system releases/upgrades
- Build effective working relationships and collaborate with other domain and enterprise resources to ensure system validation needs are being met.
- Should be able to create and review applicable validation deliverables such as GxP Assessment, Validation Plan, URS, FRS, DS, Configuration Specification, IQ , OQ , PQ test plan , test report , Validation Summary Report etc.
- Should have experience in performing Data Migration for validated systems.
- Exposure to cloud validation , Supplier assessment.

📌 Csv Consultant (Hyderabad)
🏢 Deloitte Shared Services India
📍 Hyderabad