IT Internal Auditor responsible for auditing App and code compliance with security regulations. Working in a hybrid model in the live streaming industry with a focus on global expansion.
About the role
- Site Lead Auditor, Associate Director ensuring processes conform to regulations at Dundalk facility. Leading internal audits and maintaining compliance for vaccine product development.
Responsibilities
- Develop and implement the Site Internal Audit Program
- Launch and manage the Permanent Inspection Readiness Program
- Lead and perform internal audits including facility, system, and walkthrough audits
- Advocate for continuous improvement in Quality Management Systems
- Maintain and communicate Quality-related metrics for Site Internal Audit & Inspection Readiness programs
- Represent the Quality Management System during Health Authority Inspections and Global Audits
- Communicate audit/inspection results to stakeholders and site leaders
- Manage CAPA processes for audits and inspections
Requirements
- Bachelor’s degree in Biotechnology, Science, or relevant discipline
- 10+ years of experience in the Biopharma/Pharma Industry, including internal audit/Health Authority Inspection experience
- Strong knowledge of cGMPs, US and European cGMP guidelines, ICH, and international regulatory requirements
- Excellent communication, decision-making, people influencing, and project management skills
- Strong problem-solving and critical thinking skills with the ability to identify potential compliance issues
- Self-starter with a focus on results and a desire for continuous learning and improvement
Benefits
- Flexible working
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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