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Computer Systems Validation Lead

Remote: 
Full Remote
Experience: 
Expert & Leadership (>10 years)
Work from: 

Offer summary

Qualifications:

At least 10 years of experience in computer systems validation with GMP/GxP regulations, Prior experience with FDA 21 CFR Part 11 and Enterprise systems like SAP and/or MES.
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RxCloud Pharmaceuticals Startup https://www.therxcloud.com/
11 - 50 Employees
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Job description

  • At least 10 years of experience supporting and/or performing all aspects of computer systems validation activities including development of scalable validation strategies, documents, and perform document reviews
  • At least 7 years prior experience in computer systems validation within GMP/GxP regulated environments
  • Proven experience developing full validation documentation and testing protocols within the various SDLC phases that is scalable and maintainable to demonstrate continuous compliance
  • Experience with FDA 21 CFR Part 11
  • Experience with the validation of Enterprise systems SAP and/or MES system Preferred. Validation of Life sciences systems such as Veeva, Trackwise, Argus, Clnical, Quality systems highly desired. 
  • Broad understanding of the test management Tools, including experience and knowledge Microfocus ALM, ValGenesys etc preferred.
  • Knowledge and experience around CSA highly preferred. 


Required profile

Experience

Level of experience: Expert & Leadership (>10 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

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