Computer Systems Validation Specialist

2 days 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. The ideal candidate will have a strong background in computer systems validation, with a minimum of 10 years of experience in supporting and/or performing all aspects of computer systems validation activities.

Key Responsibilities:

  • Develop scalable validation strategies, documents, and perform document reviews
  • Lead the development of full validation documentation and testing protocols within the various SDLC phases
  • Ensure continuous compliance with regulatory requirements, including FDA 21 CFR Part 11
  • Validate Enterprise systems, such as SAP and/or MES systems, and Life sciences systems, such as Veeva, Trackwise, and Argus
  • Utilize test management tools, including Microfocus ALM and ValGenesys
  • Have a broad understanding of CSA and its applications

Requirements:

  • At least 10 years of experience in computer systems validation
  • At least 7 years of prior experience in computer systems validation within GMP/GxP regulated environments
  • Proven experience in developing full validation documentation and testing protocols
  • Experience with FDA 21 CFR Part 11 and CSA
  • Knowledge of test management tools, including Microfocus ALM and ValGenesys

Preferred Qualifications:

  • Experience with the validation of Life sciences systems, such as Veeva, Trackwise, and Argus
  • Knowledge of CSA and its applications


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