Compliance Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeCompliance Full time €45,000 - €55,000

Job Title:

Quality Assurance Specialist

About the Role:

The Quality Assurance Specialist plays a pivotal 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.

Duties and Responsibilities:

Quality Management & Compliance:

  • Oversee 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

Regulatory:

  • 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 labeling, promotional materials, and advertising to ensure regulatory compliance

Pharmacovigilance & Safety:

  • 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

Validation & System Control:

  • Oversee validation of systems, equipment, and processes involved in distribution
  • Ensure compliance with data integrity

Training & Development:

  • 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

Supplier & Warehouse Oversight:

  • 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

Product Release:

  • Ensure that pharmaceutical and medical device products meet quality and regulatory standards prior to release for distribution

Change Control:

  • Manage the change control process for systems, products, and procedures, assessing potential risks and regulatory impacts
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