Computer System Validation (CSV Lead)

Job Title: Computer System Validation (CSV) and Quality Assurance Lead – Pharmaceutical Manufacturing

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Job Type:

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About the Role:

CSV and Quality Assurance Lead

This role combines leadership in CSV practices with hands-on Quality Assurance testing oversight, working closely with cross-functional teams across IT, Quality, Manufacturing, and Engineering.

Key Responsibilities:

Validation Leadership & QA Testing

• Review and approve SDLC deliverables and validation documentation for GxP-regulated computerized systems.
• Oversee the development and execution of validation test plans and test scripts for system implementations and changes.
• Provide Quality Assurance leadership in testing activities, including defect tracking, resolution, retesting, and ensuring complete traceability.
• Review and approve compliance plans, user requirements, traceability matrices, and validation summary reports.
• Ensure proper documentation and rigorous testing practices are followed to meet audit and inspection readiness standards.

Compliance & Risk Management

• Maintain current knowledge of applicable regulations (21 CFR Part 11, GAMP, ALCOA+, Data Integrity).
• Ensure validation efforts align with quality and compliance standards to minimize regulatory risk.
• Participate in audits and inspections; review and approve CAPA plans related to audit findings.
• Own, maintain, and revise CSV-related SOPs, policies, and work instructions.

Team & Project Leadership

• Lead and mentor a team of CSV and QA professionals across various validation projects and system lifecycles.
• Provide strategic CSV support for process improvements, site projects, and system upgrades.
• Collaborate with senior stakeholders to ensure business needs align with validation and compliance expectations.

Stakeholder & Cross-Functional Engagement

• Work closely with project managers, system owners, IT, and QA teams to deliver compliant and efficient systems.
• Serve as the subject matter expert for validation throughout the SDLC and post-implementation phases.

Qualifications:

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field (or equivalent experience).

• Minimum 5 years

   of experience in 

  Computer Systems Validation (CSV)

   or 

  QA Testing

   in a regulated pharmaceutical or biotech environment.
• Strong knowledge of 

  GxP

  , 

  21 CFR Part 11

  , 

  EU Annex 11

  , 

  GAMP 5

  , and 

  Data Integrity

   principles.
• Demonstrated expertise in 

  QA testing

  , including test case creation, test execution, and defect resolution.
• Experience validating GxP-related systems.
• Experience leading validation and QA testing teams.
• Excellent analytical, documentation, and communication skills.

Preferred Qualifications:

• Exposure to cloud/SaaS-based GxP system validation.
• Certifications such as PMP, ASQ, or GxP/CSV-related credentials.