Senior Auditor Enterprise Quality Auditing
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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.
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