| Senior Pharma Audit Specialist_OMAHA at Remote, Remote, USA |
| Email: [email protected] |
| From: Sachin Noulakha, Scalable systems [email protected] Reply to: [email protected] Hi This is TCS requirement. Please share me your resume with contact details and visa of your at [email protected] Senior Pharma Audit Specialist OMAHA Contract requirements Dedicated 8 + yrs of Pharma Audit Experience for SOX, GXP Applications and Technical PlatformsGood Understanding of US FDA and other Pharma Regulations updates.Hands on exp 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 Thanks, Sachin Noulakha [email protected] Keywords: Senior Pharma Audit Specialist_OMAHA [email protected] |
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| Sat Mar 30 01:25:00 UTC 2024 |