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Regulatory compliance specialist - pharmaceutical operations

Dublin
beBeeRegulatory
Compliance specialist
Posted: 2 August
Offer description

Quality Compliance Professional

This role involves ensuring pharmaceutical and medical device operations adhere to Good Distribution Practice (GDP) regulations.

As a key figure in our quality and regulatory function, you will provide expert guidance on quality management systems, product release, validation, supplier management, and pharmacovigilance activities.

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Key Responsibilities:

* Ensure compliance with GDP and regulatory requirements across pharmaceutical and medical device operations
* Provide expert guidance and support on quality management systems, product release, validation, supplier management, and pharmacovigilance activities
* Manage audits and corrective actions, including root cause analysis and implementation of CAPAs
* Maintain and control documentation, including SOPs, records, and batch release documents
* Lead and participate in internal and external audits, including preparation, execution, and follow-up on findings
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Requirements:

* Qualified Pharmacist with Responsible Person eligibility
* 1-3 years working in a similar role; Quality, Compliance (Pharma / Medical Device Business)
* Auditor Certified (e.g., ISO 9001 and/or ISO 13485 or Pharma Equivalent)
* Strong knowledge of GDP, GMP, MDR, IVDR, and Local Regulatory Framework
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What We Offer:

* Annual Bonus
* Group Life Assurance
* Laptop
* Parking
* Pension Fund
* Performance Bonus
* Work From Home

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