SOX, GXP Developer

Pharma Audit Specialist

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 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 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