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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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