| Need Pharma Audit Experience Consultant at Omaha, Nebraska, USA |
| Email: [email protected] |
| From: Sanjay, K&K Global Talent and Solutions Inc [email protected] Reply to: [email protected] Job Title: Pharma Audit Experience Consultant Location: OMAHA,NE / onsite Job Description: SOX, GXP Applications and Technical Platforms, US FDA and other Pharma Regulations Role Description: 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 Table top exercises Competencies: Regulatory Reporting and Compliance Management Keywords: Colorado Nebraska Need Pharma Audit Experience Consultant [email protected] |
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| Mon Apr 01 20:51:00 UTC 2024 |