Why Endo?
We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
Job Description Summary
Independently organizes and performs 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. Possess sound technical knowledge and auditing experience in multiple areas, such as API, Analytical Laboratories, Sterile Drug Product, Contract Packaging, Mock PAI, etc.
Job Description
Key Accountabilities – key outcomes/deliverables, the major responsibilities, and % of time
Responsibilities
85% of Time:
- Supports the audit program by independently conducting internal and external 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
- Prepares audit reports and communicates findings to external and internal stakeholders
- Tracks audit responses and auditee’s CAPAs through completion and closeout
- Expand technical knowledge and auditing experience as lead auditor across the range of branded product suppliers (i.e. API, Sterile Drug Product, Mock PAI, etc.)
- Support collection and collating of applicable key auditing performance parameters in contribution of reporting metrics
15% of Time:
As related to Enterprise Quality Auditing Functions:
- Provides guidance for continuous improvement to ensure compliance with regulations and current industry standards
- Assists in the evaluation of metrics to determine trends and opportunities for continuous improvements
- Participates in the development and implementation of EQA programs, policies, procedures, agreements & controls
- Participates in periodic audit review meetings
- Supports regulatory agency and external third party audits
- Participates in Mock PAIs of internal sites & CMOs to prepare for audits and assess gaps in the system
EEO Statement:
At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.
