Senior Auditor Enterprise Quality Auditing

Role Description

This role involves independently organizing and performing quality audits under general direction. The audits include suppliers/vendors, third parties, Endo’s business units, and internal manufacturing sites that support marketed drug products to ensure products, controls, policies, and processes meet Pharmaceutical/Biotechnology industry quality standards.

• Participates in Pre-Approval Mock Inspections to prepare internal & CMO facilities for regulatory inspections and assesses gaps in the quality systems and overall infrastructure.
• Provides cGMP guidance for continuous improvement projects to ensure compliance with regulations and current industry standards.
• Assists in the evaluation of metrics to determine trends and opportunities for continuous improvements.
• Provides support during regulatory agency and external third party inspections.
• Possesses sound technical knowledge and auditing experience in multiple areas, such as API, Analytical Laboratories, Sterile Drug Product, Contract Packaging, Mock PAI, etc.

Qualifications

• Experience in conducting internal and external audits.
• Technical knowledge in Pharmaceutical/Biotechnology industry standards.
• Ability to prepare audit reports and communicate findings effectively.

Requirements

• Supports the audit program by independently conducting audits or participating as an audit team member.
• Contributes to the development of the annual audit plans and schedules.
• Schedules audit activities and provides audit agenda.
• Tracks audit responses and auditee’s CAPAs through completion and closeout.
• Expands technical knowledge and auditing experience as lead auditor across the range of branded product suppliers.
• Supports collection and collating of applicable key auditing performance parameters in contribution of reporting metrics.

Benefits

• Commitment to equal employment opportunity.
• Supportive work environment focused on collaboration and respect.