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SOX, GXP Developer

omaha, ne • Posted 3 days ago
Onsite Contract General

SOX, GXP DeveloperLocation: Omaha NE (Onsite) Duration: Contract Experience: 8+Job DescriptionDedicated 8+ years of Pharma Audit Experience for SOX, GXP Applications and Technical PlatformsGood understanding of US FDA and other Pharma Regulations updates.Hands on experience of leading assessment discussions with Corporate Auditors and External Audit TeamSupport data evidence phase for external governmental inspectionsLead assessment discussions with Corporate Auditors and External Audit TeamDrive improvements to achieve zero Level 1/Level 2 Audit findingsAssist in identifying, eliminating or refining data requests which are obsolete and/or ambiguousDevelop a BAP Audit PlaybookTrain and mentor audit team with the goal of transitioning audit responsibilities over a periodDraft and update governance documents (SOPs, WIs, etc.) pertaining to backup, storage, platform, and Data Centers/Server Rooms.Build a self-service checklist for audit and inspection readinessDesign and drive closure of remediation activities coming out of AuditsCo-chair annual Business Continuity / Disaster Recovery Tabletop exercises

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