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CSV Validation Engineer

Anveta

Computer Systems Validation SpecialistDefine validation strategy for computerized systems and platforms utilized in GxP space.Create validation deliverables such as validation plan, test protocols, traceability matrix and execution of protocolsParticipate in user review meetings, discussions with quality assurance and compliance groupsParticipate/conduct risk assessmentsDevelop and maintain policies and proceduresEffectively communicate the validation activities and deliverables to the project team, customer stakeholders and global team within ZifoAct as a liaison between Zifo remote teams and customers in US & CanadaParticipate in internal initiatives around computer systems validationQualificationsBachelor or master's degree in lifesciences or computer sciences7-10 years' experience with computer systems validation is required for this roleStrong knowledge of GxP requirements, GCP regulations, 21 CFR part 11 requirementsMust have experience with validation of IT infrastructure systems including R, SAS etcExperience with GxP systems validation like ELN, LIMS, QMS etcExperience with Veeva vault systemsClinical experience is must.

Vacancy posted 4 days ago
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