Csv Consultant

Deloitte Shared Services India; Hyderabad, Bengaluru; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Deloitte Shared Services India is seeking a Senior Consultant to lead CSV activities in Hyderabad for SAP environments. You will validate enterprise systems, coordinate validation deliverables, and ensure regulatory alignment across GMP, 21 CFR Part 11, and EU Annex 11.

The role requires 4+ years in QA/CSV in life sciences, strong collaboration with IT and business teams, and hands-on experience with ERP/MRP/QMS/LIMS implementations, including data migration and cloud validation aspects.

Qualifications

• 4+ years of experience in QA and/or CSV in regulated LSHC environments.
• Familiar with GMP, 21 CFR Part 11, EU Annex 11.
• Proven ability to develop validation docs (URS, FRS, IQ/OQ/PQ, VSR).
• Experience with data migration for validated systems.
• Exposure to cloud validation and supplier assessment.

Responsibilities

• Define and execute end to end validation activities for IT projects and system releases/upgrades.
• Set up validation strategy to ensure agility & speed in delivery.
• Support development of BRDs, technical designs, test strategy and plans.
• Build relationships with domain/enterprise resources to meet validation needs.
• Create and review validation deliverables such as IQ, OQ, PQ, test reports, Validation Summary Report.

Skills

Quality assurance

Regulatory knowledge

Validation expertise

Stakeholder collaboration

Data migration

Tools

ERP

MRP

QMS

LIMS

Cloud validation

Job description

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 environment 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.