Compute System Validation Engineer
Karwell TechnologiesWilmington, DE
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Overview
Remote
On-site
Job Description
Roles & Responsibilities :
- 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic reviews, access roster and audit trail reviews, Deviation/CAPA management, SOP/policy compliance processes
- Authoring of URS/FS, protocols, final reports, validation plan/report
- High-level understanding of Veeva Vault suits
- Risk-based testing aligned to CSA fundamentals
- High-level understanding of Biostatistics, Clinical, Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, RPA GxP BOTs, R&D AI GxP
Education & Experience :
- Bachelor of Science OR Bachelor of Technology OR Bachelor's in Pharmacy
- Experience: Over 8+ years of overall experience with at least 5 years of experience in Computer System validation for GxP system
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FAQs About Compute System Validation Engineer Jobs at Karwell Technologies
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This job at Karwell Technologies is located in Wilmington, DE, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Karwell Technologies?
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