Job Summary

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 Positive 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

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

Must Have Skill

Life-Sciences (GxP/FDA/CSV/IQ/OQ/PQ)

Good to Have Skill

Other Requirements

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

📌 Sr Consultant (India)
🏢 HCLTech
📍 India