Responsibilities: Execute validation activities in computerized system and ensure 21 CFR part 11 compliance. Knowledge in GAMP. Preparing trace matrix to ensure requirements are tested to meet the software intended use. Preparing risk...
Responsibilities: Support timely review of all GMP documents (batch records/analytical specifications, data, validation protocols/reports, COAs, deviations, change controls, etc.) and ensure alignment with quality and regulatory expectati...
Responsibilities: Provide CSV support for VEEVA eQMS (Change Control, CAPAs, Deviations) and initial LIMS phase. Contribute to Oracle ERP phase 2 and Master Control EBR implementations. Support CSV for Trace link and serialization sof...