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CSV Validation Engineer
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- Experience in FDA and/or Global regulated environment with good understanding of GCP , GLP and Risk based validation strategy.
- Provides consultation and counseling on Risk and Compliance module implementation in reference to regulatory quality.
- User Stories, URS, FRS).
- Lead, Write, Review / Approve Requirement Traceability Matrix (RTM) and Validation Summary Reports.
- Experience in Clinical systems like CTMS, CDMS, EDC, Veeva Vault, QMS and Safety Systems and Infrastructure Qualification.
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