Quality Assurance Specialist

Quality Assurance & Regulatory Compliance Manager

The Quality Assurance and Regulatory Compliance Manager plays a critical role in ensuring compliance with Good Distribution Practice (GDP) and regulatory requirements across pharmaceutical and medical device operations.

This involves support of quality systems, product release, validation, and supplier management. The successful candidate will maintain regulatory licenses, manage pharmacovigilance and vigilance activities, handle audits and CAPAs, and ensure up-to-date documentation and training programs.

Key responsibilities include overseeing GDP activities for pharmaceutical and medical device products, ensuring temperature control and environmental monitoring of storage and distribution areas, managing quality operations including deviation/NC handling, root cause analysis, and implementation of corrective and preventive actions (CAPAs).

The ideal candidate will have strong knowledge of GDP, GMP, MDR, IVDR, and local regulatory frameworks, as well as experience in regulatory, medical information or pharmacovigilance roles. A qualified pharmacist with auditor certification and responsible person eligibility is preferred.

Benefits include a competitive salary, annual bonus, pension, parking, canteen, paid annual leave, and educational assistance.

Responsibilities:

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• Quality Management & Compliance:">
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  • Oversee Good Distribution Practice (GDP) activities for pharmaceutical and medical device products">
  • Ensure temperature control and environmental monitoring of storage and distribution areas">
  • Manage quality operations, including deviation/NC handling, root cause analysis, and implementation of corrective and preventive actions (CAPAs)">
  • Perform risk assessments for distributed products and processes in line with regulatory and company standards">
  • 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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  • Regulatory:">
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    • Prepare, submit, and maintain facility licenses, registrations, and renewals with national and international regulatory bodies">
    • Oversee compliance with Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) requirements">
    • Monitor regulatory updates and assess business impact (regulatory intelligence)">
    • Review and approve product labelling, promotional materials, and advertising to ensure regulatory compliance">
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    • Pharmacovigilance & Safety:">
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      • Manage pharmacovigilance and medical device vigilance activities, including adverse event reporting and follow-up">
      • Handle product complaints and coordinate recalls in line with regulatory expectations and internal procedures">
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      • Validation & System Control:">
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        • Oversee validation of systems, equipment, and processes involved in distribution">
        • Ensure compliance with data integrity">
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        • Training & Development:">
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          • Develop, maintain, and deliver training programs to ensure all staff comply with GDP, GMP, and quality policies">
          • Ensure training records are complete and up to date">
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          • Supplier & Warehouse Oversight:">
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            • Qualify and manage suppliers and third-party service providers, including audits and performance monitoring">
            • Support warehousing operations to ensure GDP compliance, including good housekeeping, pest control, and material handling">
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            • Product Release:">
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              • Ensure that pharmaceutical and medical device products meet quality and regulatory standards prior to release for distribution">
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              • Change Control:">
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                • Manage the change control process for systems, products, and procedures, assessing potential risks and regulatory impacts">
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Requirements:

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• Qualified Pharmacist">
• 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">
• 1-3 years' experience in Regulatory, Medical information or Pharmacovigilance">

Salary Information:

€45k – €55k Basic (Dependent on Experience)

Annual Bonus, Pension, Parking, Canteen, Paid Annual Leave, Educational Assistance

How to Apply:

Please submit your application with a detailed CV and cover letter outlining your relevant experience and qualifications for this role.