Senior Consultant | CSV | Hyderabad | SAP | DSA LS&HC
Deloitte (company site, opens in a new tab)8+ yrsHyderabadOn-siteDirect career pageEst. 18–28 LPA
Posted on 2 Sept
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Job description
Structured overview of role & requirements
About This Role
- Plan, execute, and maintain Computer System Validation activities for GxP-regulated systems in Life Sciences and Healthcare domains.
- Set up and own validation strategy ensuring agility and speed in delivery, including end-to-end validation of IT projects, system releases, and upgrades.
- Develop and review validation deliverables (e.g., Validation Plan, Test Strategy, URS, IQ/OQ/PQ) and support regulatory compliance including audits and supplier assessments.
Minimum Requirements
- Minimum 8 years’ experience in quality assurance and/or computerized system validation in regulated Life Sciences and Healthcare environment.
- At least 5 years’ hands-on experience as a Computer System Validation professional with domain systems like ERP, MRP, QMS, or LIMS supporting global operations.
- Deep knowledge of regulatory requirements including GMP, 21 CFR Part 11, 21 CFR Part 820, and EU Annex 11.
- Work Experience Required: 8+ years as described; Location: Hyderabad
Ideal Candidate Profile
- Experienced in setting and executing validation strategies that balance speed and regulatory rigor within GxP contexts.
- Comfortable working in complex regulated environments with evolving technologies including cloud and AI/ML system validations.
- Proven ability to collaborate effectively with cross-functional teams and interface with auditors and external stakeholders.