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Tier-1 employer and metro location increase competition, but niche GxP CSV specialization reduces applicant pool.
Requires life-sciences GxP validation expertise, limiting cross-industry transferability.
Explicit 8+ years requirement and mandatory GxP-regulated CSV expertise make shortlisting highly strict.
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 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
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.