Advancing Pharmaceutical Quality

1 day ago

Castlebar Municipal District, Ireland beBeePharmaceutical Full time €40,000 - €60,000

**Job Title:** Quality Assurance Specialist

We are seeking a skilled Quality Systems professional to join our team. This is a key role ensuring compliance with Good Manufacturing Practice (GMP) standards and supporting quality functions across the site.

  • Act as Subject Matter Expert for validation, change control, laboratory systems, incidents, microbiology, Quality Agreements, Annual Product Reviews, and Quality Council coordination.

  • Manage regulatory data, site licenses, and support audits/inspections.

  • Lead and participate in continuous improvement and cross-functional quality initiatives.

Responsibilities:

  • Validation and Change Control:

    • Process validation, cleaning validation, equipment validation, water validation

    • Change control process management

  • Laboratory Systems:

    • Quality assurance oversight for laboratory systems

    • Incident management and reporting

    • Microbiology support

  • Quality Agreements and Compliance:

    • Quality Agreement management

    • Annual Product Review coordination

    • Quality Council facilitation

  • Audit and Inspection Support:

    • Regulatory data management

    • Site license management

    • Audit and inspection support

Requirements:

  • GMP experience and pharmaceutical quality systems knowledge

  • Validation, change control, and regulatory compliance expertise

  • Excellent documentation, communication, and analytical problem-solving skills

  • Proficiency in systems such as SAP, GLIMS, and Microsoft Office

This is an excellent opportunity to join a high-performing quality team committed to excellence in manufacturing and compliance.

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