Computer Systems Validation Lead
4 weeks ago
Job Description Summary: Lead regulated computer systems validation activities, focusing on scalable validation strategies, document development, and review, in GMP/GxP environments for RxCloud.
Key Responsibilities:
- Develop full validation documentation and testing protocols within SDLC phases.
- Ensure continuous compliance through scalable and maintainable validation strategies.
Required Experience:
- At least 10 years of experience in computer systems validation.
- 7+ years of experience in GMP/GxP regulated environments.
- Experience with FDA 21 CFR Part 11.
Preferred Experience:
- Validation of Enterprise systems SAP and/or MES.
- Validation of Life sciences systems such as Veeva, Trackwise, Argus, Clinical, Quality systems.
- Broad understanding of test management tools, including Microfocus ALM and ValGenesys.
- Knowledge and experience around CSA.
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