CSV Lead

1 day ago


Pacific Remote Islands Marine National Monument, India Ntech IT Solutions Private Limited Full time

Role: CSV Lead

Type: Contract

Location: Remote

Experience: 4+ Years

Start: Immediate joiner only

Responsibilities

Lead Computer System Validation (CSV) activities for SAP S/4HANA Supply Chain & Warehouse Management modules

Define and drive validation strategy in a GxP-regulated pharma environment

Prepare validation deliverables (Validation Plans, Test Plans, PQ, Validation Summary Reports, SOPs)

Partner with SAP teams to document workflows, processes, and validation deliverables

Ensure compliance with GMP, GxP, and 21 CFR Part 11 (audit trails, access management, electronic records)

Support audits, inspections, change control processes, and periodic system reviews

Advise project and QA teams on data integrity and validation best practices

Requirements

Strong experience as a CSV Lead in the pharma/life sciences industry

Hands-on validation expertise (risk-based validation, PQ, compliance documentation)

Prior SAP S/4HANA project experience, ideally in Supply Chain/Warehouse modules

Knowledge of GxP, GMP, and FDA regulatory guidelines

Experience handling audits and regulatory inspections

Able to join immediately

Job Type: Contractual / Temporary
Contract length: 12 months

Pay: ₹6, ₹10,000.00 per day

Experience:

  • Pharma/life sciences industry: 4 years (Required)
  • Computer System Validation (CSV): 4 years (Required)

Work Location: Remote


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