Principal Auditor, Enterprise Quality Auditing

3 weeks ago


Dublin, Dublin City, Ireland Endo International Full time
Why Join Endo?

We are looking for top talent to join Endo and help us in our mission to develop and deliver life-enhancing products through focused execution.

  • Our global team of nearly 3,000 members recognizes the vital role we play in providing healthcare and is committed to supporting each other as we strive to offer the best treatments.
  • Our core values of Integrity & Quality, Innovation, Drive, Collaboration, and Empathy drive our team and empower us to realize our goal of assisting everyone we serve in living their best life.

At Endo, we are actively working on creating a diverse, fair, and inclusive workplace, and we are seeking skilled individuals to become part of our team.

Job Description
  • Independently organizes and conducts quality audits for Endo's Branded Pharmaceuticals.
  • Performs audits on suppliers/vendors, third parties, Endo's business units, and internal manufacturing sites ensuring adherence to industry quality standards.
  • Leads Pre-Approval Mock Inspections to prepare CMO facilities for regulatory checks and identify areas for improvement in quality systems.
  • Participates in cGMP projects for continuous enhancement, interacts with regulatory bodies during inspections, and analyzes metrics for opportunities to excel.
  • Brings extensive experience and technical proficiency across various audit areas.
Key Responsibilities
  • Auditing - 85%
  • Manages audit metrics program, conducts audits, and analyzes quality systems for compliance risks.
  • Contributes to audit plans, collects performance metrics, and presents reports to stakeholders.
  • EQA Department Support - 15%
  • Develops and implements EQA programs, leads Mock PAIs, and assists in FDA inspections.
  • Facilitates continuous improvement efforts and evaluates performance metrics.
Qualifications
  • Education & Experience
  • Minimum BA/BS with over 10 years' experience in pharmaceutical manufacturing or Quality Assurance/Compliance.
  • ASQ-CQA or ASQ-CQE certification preferred.
  • Knowledge
  • Proficiency in FDA regulations, GMP/GLP/GCP, Lean Manufacturing, and Six-Sigma.
  • Thorough understanding of domestic and international standards related to pharmaceuticals.
  • Skills & Abilities
  • Strong technical background in pharmaceuticals, ability to review technical documents, conduct GMP audits, and lead quality incident investigations.
  • Proficient in Word, Excel, Power Point, and Outlook with excellent communication skills.
Physical Requirements
  • Ability to walk across factory/warehouse.
  • International Travel (45%).
Commitment to Diversity, Equity, and Inclusion

At Endo, diversity is our strength, and we are dedicated to fostering an inclusive culture that values each individual's unique perspective.

EEO Statement

Endo upholds equal employment opportunity principles and ensures a work environment where all employees feel respected and valued regardless of their background.


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