CSV (Computer System Validation)

Company Description

CPF - Center of Pharma Force is a professional platform fostering learning, growth, and collaboration among pharmaceutical industry professionals. Through CPF, individuals can share insights, thoughts, and updates on regulations relevant to India and global markets. The platform emphasizes mentorship, encouraging industry experts to train junior professionals and contribute to their career development. CPF aims to build a robust knowledge-sharing community to empower professionals and drive collective skill advancement.

Role Description:

1. Validation Planning & Strategy

• Develop and execute CSV strategies aligned with

  GAMP 5

  and regulatory expectations.
• Prepare validation deliverables including

  Validation Plan (VP), URS, RA, IQ, OQ, PQ

  , and Summary Reports.
• Perform risk-based assessments for systems and determine validation scope.

2. System Lifecycle Management

• Support SDLC activities from requirements gathering to system retirement.
• Ensure proper documentation throughout

  design, testing, deployment, change control, and periodic review

  .

3. Testing & Execution

• Develop test protocols and scripts aligned with system functionality.
• Execute and/or review IQ/OQ/PQ activities.
• Manage defects, deviations, and ensure timely resolution.

4. Compliance & Data Integrity

• Ensure adherence to

  21 CFR Part 11, Annex 11, GxP, ALCOA+

  principles.
• Perform periodic audits / assessments of computer systems.
• Ensure validated state is maintained through change management.

5. Stakeholder Collaboration

• Work closely with QA, IT, manufacturing, QC, R&D, and vendors.
• Provide compliance guidance during system implementation or upgrades.
• Participate in vendor qualification and software evaluation processes.

6. Documentation & Reporting

• Review system documentation (URS, FS, DS, traceability matrix, test scripts).
• Maintain validation repositories and ensure audit readiness.
• Prepare validation summary reports and maintain traceability matrices.

7. Training & Support

• Train teams on CSV methodologies and regulatory expectations.
• Support internal/external audits and regulatory inspections.

Qualifications

• Bachelor’s degree in Computer Science, Engineering, Pharmaceutical Sciences, or related fields
• Experience in computer system validation for pharmaceuticals is a mandate

• Experience in Programming and technical problem-solving skills
• Knowledge and hands-on experience in Machining and related technical processes
• Ability to conduct training and mentor colleagues, demonstrating strong Teaching skills
• Understanding of regulatory requirements in pharmaceutical manufacturing
• Detail-oriented with strong analytical and documentation skills