IT - Computer System Validation (CSV) Specialist

Azurity Pharmaceuticals - India
Hyderabad, IN
Job Description
Azurity Pharmaceuticals is seeking an IT - Computer System Validation (CSV) Specialist with expertise in the pharmaceutical domain. This role ensures compliance with industry standards, including 21 CFR Part 11, Annex 11, GxP, and other regulatory frameworks. The specialist will be responsible for validating systems and supporting digital transformation initiatives, collaborating across teams to maintain stringent compliance and build trust in digital systems.

Requirements

  • Develop, review, and execute IT-CSV deliverables.
  • Conduct risk assessments and prioritize testing.
  • Ensure compliance with regulations and internal SOPs.
  • Provide subject matter expertise on IT impacts.
  • Interface with IT and business stakeholders.
  • Create and maintain documentation.
  • Work on-site in Hyderabad (modified shift) with partial US overlap.
  • Excellent verbal and written English skills.
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