SOX, GXP Developer
Syntricate Technologies
SOX, GXP Developer
Location: Omaha NE (Onsite) Duration: Contract Experience: 8+
Job Description
Dedicated 8+ years of Pharma Audit Experience for SOX, GXP Applications and Technical Platforms
Good understanding of US FDA and other Pharma Regulations updates.
Hands on experience 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 Centers/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
Syntricate TechnologiesVacancy posted 4 days ago
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