Validation Test Lead

Were Hiring | CSV Validation Lead | 10+ Years

Are you an experienced Computer System Validation (CSV) professional with strong expertise in GxP regulated environments?

We are looking for a CSV Validation Lead who can drive validation strategy, lead testing teams, and ensure compliance for regulated systems in the Life Sciences / Pharma / Biotech industry.

Location: Hyderabad (Remote)

Experience: 10+ Years

Industry: Life Sciences / Pharma / Biotech

Employment Type: Full-Time

Key Responsibilities

Lead validation testing activities for GxP-regulated systems

Manage and mentor a team of validation testers

Drive end-to-end validation lifecycle activities

Prepare and review validation documentation (URS, FRS, IQ, OQ, PQ, RTM, VSR)

Ensure compliance with 21 CFR Part 11, EU Annex 11, and GAMP 5

Oversee test case design, review, and execution

Manage defects, deviations, and validation risk assessments

Collaborate with QA, IT, business stakeholders, and vendors

Provide status reporting, metrics tracking, and project updates

Required Skills

10+ years of Computer System Validation (CSV) experience

35 years of validation team leadership experience

Hands-on experience with Polarion ALM (Mandatory)

Experience with HP ALM, Jira, Tricentis (Preferred)

Basic automation knowledge (Selenium / JMeter)

If you are passionate about validation, regulatory compliance, and leading validation teams, we would love to hear from you.

Interested candidates can share their resume or comment below.

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