Senior Compliance Specialist

2 weeks ago


Dublin, Dublin City, Ireland beBeeRegulatory Full time €80,000 - €100,000

Quality Assurance plays a vital role in ensuring the integrity and efficacy of our products. As a Senior Quality Specialist, you will oversee and maintain the Quality Management System (QMS), guaranteeing it is fit for purpose.

You will be responsible for approving SOPs and quality system documentation while maintaining compliance with WDA, MIA, and ASR authorisations. Additionally, you will act as QP/RP and liaise with regulatory bodies on behalf of the company.

Your duties will also include supporting inspections, preparing written responses, and overseeing quality aspects of new product introductions. You will review and approve non-conformances, CAPAs, change controls, and complaints. Furthermore, you will manage supplier and customer GDP compliance reviews, ensure GMP-compliant batch record review before release, and prepare technical agreements with partners and third parties.

In this position, you will conduct internal audits and management reviews, leading the implementation of continuous improvement initiatives within quality operations.

  • BSc (Hons) in Science or equivalent
  • Eligible to act as a Qualified Person (QP) under Directive 2001/83/EC and 2003/94/EC
  • Eligible to act as a Responsible Person (RP) per EU GDP guidelines preferred
  • Minimum 5 years' experience in Quality Assurance within the healthcare industry
  • Strong understanding of GMDPs and regulatory expectations
  • Experience with internal audits and HPRA inspections
  • Excellent analytical, communication, and leadership skills


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