Computer Systems Validation Lead
rxcloudMillbrae (CA)
About the role
About the job:
Computer Systems Validation LeadAt 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 systemsSAP and/or MES system Preferred. Validation ofLife sciences systems such as Veeva, Trackwise, Argus, Clnical, Qualitysystems highly desired.
Broad understanding of the test managementTools, including experience and knowledge Microfocus ALM, ValGenesysetc preferred.
Knowledge and experience around CSA highly preferred.
Before you apply
Applying takes about a minute. These four things decide how fast it moves after that.
Your profile is current
It's what we read first. Occupations, seniority and locations matter more than a long history.
Two examples you can talk through
Not a portfolio — just two pieces of work where you can explain the decisions and what you'd change.
A number in mind
What you're on now and what would make you move. We negotiate better when we know both.
Your notice period
Employers plan around it, and it's the question that stalls offers most often.
Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.
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