Senior Validation Specialist

3 days ago


Bengaluru, Karnataka, India 518c6aa2-d08a-45a7-97db-d037b1c62852 Full time ₹ 12,00,000 - ₹ 24,00,000 per year

Job Title: Computer System Validation (CSV) Specialist

Remote: India - Only

Key Responsibilities:

  • Develop and execute Abiomed's remediation activities for CSV, assessing, planning, and enhancing Abiomed's CSV processes and execution in alignment with J&J MedTech standards.
  • Develop and execute validation plans for new and existing GxP computer systems and digital solutions.
  • Lead and/or support various SDLC and Software V&V activities, including Requirements Analysis, Validation Plan & Report, testing, qualification, and other activities necessary to meet CSV deliverables.
  • Create and maintain validation documentation, including test protocols, reports, and risk/compliance assessments.
  • Conduct assessments and periodic reviews of validated systems to ensure compliance with regulatory requirements and Abiomed procedures.
  • Provide CSV Subject Matter Expert (SME) support to system owners and users.
  • Collaborate with other QA team members to support the development and implementation of quality improvement initiatives.

Education:

  • University/Bachelor's degree or equivalent is required.
  • Degree concentrations in Computer Science, Engineering, Life Sciences, Data Science, or related fields are an asset.

Experience and Skills Required:

  • 4–6 years of related experience in computer system validation within MedTech or Pharma.
  • Strong knowledge of 21 CFR Part 11, EU Annex 11, ISO 13485, ISO 82304, FDA CSA, MDSAP, and other relevant regulatory requirements.


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