Computer Systems Validation Lead

2 weeks ago


San Francisco, California, United States RxCloud Full time
About the Job

At RxCloud, we are seeking a highly experienced Computer Systems Validation Lead to join our team. As a key member of our validation team, you will be responsible for developing and implementing scalable validation strategies, documents, and protocols to ensure continuous compliance with GMP/GxP regulations.

Key Responsibilities
  • Develop and implement validation strategies, documents, and protocols for computer systems, including Enterprise systems SAP and/or MES systems.
  • Perform document reviews and ensure compliance with FDA 21 CFR Part 11.
  • Collaborate with cross-functional teams to develop and implement testing protocols within the SDLC phases.
  • Provide expertise on test management tools, including Microfocus ALM and ValGenesys.
  • Stay up-to-date with industry trends and regulatory requirements to ensure RxCloud's systems remain compliant.
Requirements
  • At least 10 years of experience in computer systems validation, with a minimum of 7 years in GMP/GxP regulated environments.
  • Proven experience developing full validation documentation and testing protocols.
  • Experience with CSA and knowledge of Life sciences systems, such as Veeva, Trackwise, and Argus.
  • Broad understanding of test management tools and experience with Microfocus ALM and ValGenesys.


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