Senior CSV Specialist

1 week ago


Bengaluru, Karnataka, India beBeeDataIntegrity Full time ₹ 15,00,000 - ₹ 20,00,000

Job Summary: We are seeking a seasoned CSV Specialist to join our team. As a key member of our organization, you will be responsible for ensuring the validation and compliance of our computerized systems.

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Key Responsibilities:

  • Perform risk-based validation activities for GxP computerized systems, including planning, assessment, and documentation.
  • Prepare and review validation documentation in line with 21 CFR Part 11, EU Annex 11, and other regulatory guidelines.
  • Conduct periodic reviews and impact assessments for existing validated systems.
  • Collaborate with cross-functional teams to ensure validation deliverables are met within timelines.
  • Guide project teams on validation requirements and risk-based approaches.
  • Ensure data integrity compliance across systems and processes.

Requirements:

  • 2-4 years of experience in computer system validation within pharmaceutical, biotech, or life-sciences industries.
  • Strong knowledge of GxP regulations, 21 CFR Part 11, EU Annex 11, and data integrity requirements.
  • Excellent documentation and communication skills.
  • Ability to work independently and in cross-functional teams.

What We Offer:

  • A dynamic and collaborative work environment.
  • Ongoing training and development opportunities.
  • The chance to work on challenging projects and contribute to the success of our organization.

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