| Pharma Audit (Regulatory Reporting and Compliance Management) at Remote, Remote, USA |
| Email: [email protected] |
| From: Venkat, KK Software Associates [email protected] Reply to: [email protected] We are hiring Pharma Audit (Regulatory Reporting and Compliance Management) for one of my Client in OMAHA (From Day 1 Onsite), interesting candidates please send resumes to [email protected] (614) 335-4419 Position: Pharma Audit (Regulatory Reporting and Compliance Management) Location: OMAHA (From Day 1 Onsite) Visa status: Strictly Dont share F1, OPT, OPT EAD, L2 EAD and H4 EAD work permit Profiles Dedicated 8 + yrs of Pharma Audit Experience for SOX, GXP Applications and Technical Platforms Good Understanding of US FDA and other Pharma Regulations updates. Hands on exp of Leading assessment discussions with Corporate Auditors and External Audit Team Support data evidence phase for external governmental inspections Lead assessment discussions with Corporate Auditors and External Audit Team Drive improvements to achieve Zero Level 1/Level 2 Audit findings Assist in identifying, eliminating or refining data requests which are obsolete and/or ambiguous Develop a BAP Audit Playbook Train and mentor audit team with the goal of transitioning audit responsibilities over a period Draft and update governance documents (SOPs, WIs, etc.) pertaining to backup, storage, platform, and Data Centres/Server Rooms. Build a self-service checklist for audit and inspection readiness Design and drive closure of remediation activities coming out of Audits Co-chair annual Business Continuity / Disaster Recovery Tabletop exercises Keywords: Colorado Pharma Audit (Regulatory Reporting and Compliance Management) [email protected] |
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| Fri Mar 29 20:04:00 UTC 2024 |