Computer System Validation Analyst with Veeva Remote role, Client based in SF Bay area - must be willing to work Pacific Time hours Our client needs intermediate to senior level CSV skills, with Veeva Vault experience (there will be three Veeva implementations this year at this company). Most importantly, seeking sharp candidates with the ability to learn quickly and work relatively fast.
Labware LIMS is a desirable skill (1 LIMS implementation scheduled), but is not mandatory.
Cloud validation and SaaS is also a plus.
Extensive experience in FDA regulated environment with strong understanding compliance issues as well as cGxP (cGMP, cGDP, cGAMP, cGLP) standards and Risk-based validation.
Will conduct computer system validation work, assuring thoroughness of validation planning and making appropriate progress towards timely completion of validation deliverables.
Will develop validation strategy documents, write user requirements, SOPs, IQ/OQ/PQ, and create validation summary reports.
Strong verbal and written communication skills are essential.