System Validation Specialist

2 days ago


Bengaluru, Karnataka, India Merck Group Full time

We are seeking an experienced System Validation Specialist to support our global Data & AI Organization in ensuring computerized systems and software applications comply with industry standards and regulatory requirements.

This role involves developing qualification and validation strategies, executing validation protocols, and maintaining documentation to support compliance efforts. The ideal candidate will have a strong background in computer system validation within a regulated industry and knowledge of regulatory guidelines (e.g., FDA, EMA, GxP, GAMP5).

Key Responsibilities:

  • Develop and execute qualification and validation plans, protocols, and reports for computerized systems and software applications.
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements and internal policies.
  • Perform risk assessments and impact analyses for computerized systems.
  • Review and approve system specifications, design documents, and change controls.
  • Conduct training sessions for staff on validation processes and compliance requirements.
  • Maintain up-to-date knowledge of regulatory requirements, industry standards, and best practices related to computer system validation.
  • Support audits and inspections by regulatory agencies and internal quality teams.
  • Troubleshoot validation issues and provide solutions to ensure compliance.

Required Skills and Qualifications:

  • 2-5 years of experience in Computer System Validation / GxP
  • Bachelor's degree with specialization in information systems, computer science, electrical engineering or similar
  • Experience in computer system validation within a regulated industry (pharmaceutical, biotechnology, medical devices)
  • Knowledge of regulatory guidelines (e.g., FDA, EMA, GxP, GAMP5) and validation methodologies
  • Experience with software development life cycle (SDLC) and validation tools


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