Senior Validation Specialist

3 weeks ago


San Francisco, California, United States RxCloud Full time

About the role at RxCloud

Job Summary

RxCloud is 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 ensuring the scalability and maintainability of our validation documentation and testing protocols.

Key Responsibilities

  • Develop and implement scalable validation strategies, documents, and testing protocols to ensure continuous compliance.
  • Perform document reviews and provide feedback to ensure high-quality validation documentation.
  • Collaborate with cross-functional teams to develop and implement validation plans and protocols.
  • Provide expertise on FDA 21 CFR Part 11 and other regulatory requirements.
  • Validate Enterprise systems, including SAP and MES systems, and Life sciences systems, such as Veeva, Trackwise, and Argus.
  • Stay up-to-date with industry trends and best practices in computer systems validation.
  • Develop and maintain relationships with key stakeholders, including business leaders and technical teams.

Requirements

  • At least 10 years of experience in computer systems validation, including development of scalable validation strategies and documents.
  • At least 7 years of prior experience in computer systems validation within GMP/GxP regulated environments.
  • Proven experience developing full validation documentation and testing protocols within the SDLC phases.
  • Experience with test management tools, including Microfocus ALM and ValGenesys.
  • Broad understanding of CSA and its applications.

Preferred Qualifications

  • Experience with Life sciences systems, such as Clinical and Quality systems.
  • Knowledge of industry trends and best practices in computer systems validation.


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