Computer System Validation (CSV) Consultant

Position: Computer System Validation (CSV) Consultant

Experience:

Department:

Reporting To:

Role Summary

CSV Specialist

Key Responsibilities

1. System Validation & Documentation

• Prepare, review, and maintain all CSV deliverables — including

  Validation Plans, URS, FS/DS, Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols,

  and

  Validation Summary Reports

  .
• Ensure all validation follows the

  GAMP 5

  lifecycle approach.
• Conduct periodic reviews, revalidation, and manage

  change control, CAPA, and deviation records.

2. Pharmacovigilance / Regulatory Systems

• Support validation of

  safety databases, signal detection tools,

  or

  regulatory submission systems.

• Maintain validated status of PV tools as per

  global regulatory

  expectations.

3. Compliance & Audit Readiness

• Ensure ongoing adherence to

  GxP, 21 CFR Part 11, Annex 11,

  and

  data integrity

  standards.
• Provide validation documentation and evidence during

  audits or inspections.

• Support system remediation and continuous compliance improvement activities.

4. Cross-Functional Collaboration

• Partner with

  QA, IT, Business,

  and

  Vendors

  to deliver validation milestones on time.
• Offer

  training and guidance

  on CSV practices and documentation standards.
• Monitor timelines and ensure deliverables meet

  project and quality requirements.

Qualifications & Competencies

• Bachelor’s or Master’s in

  Life Sciences, Computer Science, Pharmacy,

  or related field.

• 3–5 years

  of direct experience in CSV within a

  GxP-regulated

  setting.
• Proficient with

  GAMP 5, 21 CFR Part 11, Annex 11, FDA/EMA,

  and

  ICH

  guidelines.
• Strong understanding of

  risk-based validation

  and

  SDLC

  (Agile/Waterfall).
• Experience with

  Pharmacovigilance systems

  preferred.
• Excellent

  documentation, analytical,

  and

  communication

  skills.