Sr Consultant

Job description

Job Title: CSV Infrastructure Qualification (GxP) Job Description: The position is responsible for end‑to‑end CSV Infrastructure Qualification for GxP‑regulated environments, ensuring compliance with FDA, GAMP5, EU Annex 11, and client Quality Systems. The role provides quality leadership across Design & Engineering, Implementation, and BAU operations for on‑prem, virtual, cloud infrastructure, including large‑scale Server Appliance deployments across global sites. Key Responsibility CSV Infrastructure Qualification GxP compliance across infrastructure lifecycle Audit readiness and regulatory alignment Quality oversight for multi‑year, large‑scale Server Appliance implementations Roles & Responsibilities: Define qualification strategy Lead and govern execution of Infrastructure IQ, OQ activities. Ensure vendor documentation and supplier qualification evidence meet GxP expectations. Oversee change, deviation, and CAPA management during implementation. Act as Quality SPOC for project audits and client reviews. Ensure right‑first‑time qualification and inspection‑ready documentation Govern ongoing compliance of qualified infrastructure in BAU. Perform and oversee: Periodic reviews, Change impact assessments and requalification decisions, Incident, deviation, and CAPA oversight Ensure infrastructure changes, patches, and upgrades follow controlled CSV processes. Maintain continuous audit readiness for BAU environments. Technical & Regulatory Expertise GAMP 5, FDA 21 CFR Part 11, EU Annex 11 Infrastructure Qualification (on‑prem, virtual, cloud) Data Integrity (ALCOA+) Risk‑based validation and lifecycle management Qualification: Minimum - B.Pharm/M.Pharm, B.E/ B. Tech, (MBA / MCA / MTech is an added advantage) Experience: Minimum 10 years of experience in Computer System Validation Hands‑on experience in Infrastructure Qualification is mandatory, including multi‑site or large‑scale deployments Capabilities and Certifications: Professional Services background including exposure to GAMP / CSV, ITIL, Cloud certifications (AWS / Azure – GxP exposure) Must Demonstrate Good Communication and Presentation Skills Key Responsibilities Key Responsibility CSV Infrastructure Qualification GxP compliance across infrastructure lifecycle Audit readiness and regulatory alignment Quality oversight for multi‑year, large‑scale Server Appliance implementations Roles & Responsibilities: Define qualification strategy Lead and govern execution of Infrastructure IQ, OQ activities. Ensure vendor documentation and supplier qualification evidence meet GxP expectations. Oversee change, deviation, and CAPA management during implementation. Act as Quality SPOC for project audits and client reviews. Ensure right‑first‑time qualification and inspection‑ready documentation Govern ongoing compliance of qualified infrastructure in BAU. Perform and oversee: Periodic reviews, Change impact assessments and requalification decisions, Incident, deviation, and CAPA oversight Ensure infrastructure changes, patches, and upgrades follow controlled CSV processes. Maintain continuous audit readiness for BAU environments. Skill Requirements Technical & Regulatory Expertise GAMP 5, FDA 21 CFR Part 11, EU Annex 11 Infrastructure Qualification (on‑prem, virtual, cloud) Data Integrity (ALCOA+) Risk‑based validation and lifecycle management Qualification: Minimum - B.Pharm/M.Pharm, B.E/ B. Tech, (MBA / MCA / MTech is an added advantage) Experience: Minimum 10 years of experience in Computer System Validation Hands‑on experience in Infrastructure Qualification is mandatory, including multi‑site or large‑scale deployments Capabilities and Certifications: Professional Services background including exposure to GAMP / CSV, ITIL, Cloud certifications (AWS / Azure – GxP exposure) Must Demonstrate Good Communication and Presentation Skills Other Requirements Apply now Information at a Glance Why HCLTech? At HCLTech, you'll supercharge your potential. You'll find your career. And you'll find your spark. All at a place that knows that helping its customers stay on top starts by putting its people first. HCLTech is a global technology company, home to more than 223,000 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. 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