CSV Compliance Specialist

3 days ago


Bengaluru, Karnataka, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 25,00,000

Job Overview:

We are seeking a skilled CSV Specialist to join our team. The ideal candidate will have experience in computer system validation, with a strong understanding of GxP regulations and data integrity requirements.

Key Responsibilities:

  • Validate computerized systems to ensure compliance with regulatory guidelines.
  • Develop and maintain validation documentation, including risk assessments and impact analyses.
  • Collaborate with cross-functional teams to ensure validation deliverables meet project timelines.
  • Guide project teams on validation requirements and risk-based approaches.
  • Evaluate data integrity across systems and processes.

Required Skills and Qualifications:

  • 2-4 years of hands-on 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 work environment with opportunities for professional growth.
  • The chance to collaborate with experienced professionals in the field.
  • Competitive compensation and benefits package.

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