Regulatory Compliance Officer

4 days ago

Galway, Galway, Ireland beBeeQuality Full time €45,000 - €55,000
Job Title: Quality Assurance Specialist

The successful candidate will be responsible for managing routine batch release testing in our Biosafety and Cell Based Assay Department, including client communication, weekly calls, subcontractor management, and ensuring timely sample releases. Additionally, they will generate and update GMP-compliant SOPs, protocols, and reports.

Responsibilities:
  1. Manage the quality control process for batch releases, including data review, client correspondence, and scheduling tests.
  2. Generate and maintain GMP-compliant documents, such as SOPs, protocols, and reports.
  3. Source and procure consumables, standards, and reagents required for testing.
  4. Process test samples in our Laboratory Information Management System (LIMS).
  5. Perform data calculations, basic statistics, and trending to provide insights to clients.
  6. Assist in internal, regulatory, and client audits, and respond to findings.
Requirements:

To be successful in this role, you will need:

  • Minimum 2 years of relevant experience in scientific research, preferably within a GMP-regulated environment in the Pharmaceutical, Medical Device, or CRO industry.
  • Proven project management skills.
  • A degree in a relevant science discipline, such as cell biology, molecular biology, or biomedical science.
  • Desirable but not essential: experience with cell-based assays or molecular techniques.
  • Unrestricted full working rights for Ireland.

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