Regulatory Laboratory Specialist

3 days ago

Dublin, Dublin City, Ireland beBeeLaboratory Full time €60,000 - €80,000

Regulatory Laboratory Specialist

Job Overview:

We are seeking a highly skilled Regulatory Laboratory Specialist to join our team. In this role, you will be responsible for ensuring the qualification and maintenance of laboratory systems in compliance with cGMP regulations.

  • Plan, execute, and document the qualification, calibration, and routine maintenance of laboratory systems to ensure they meet cGMP requirements.
  • Ensure that all maintenance and calibration activities carried out by Calibration Technicians are tracked and managed through the Computerised Maintenance Management System (CMMS) Maximo.
  • Have specific hands-on laboratory equipment lifecycle and validation experience.
  • Key Responsibilities:
    • Conduct routine calibration, requalification, and maintenance of laboratory equipment to ensure schedules are adhered to as per CMMS Maximo.
    • Review and file QC calibration and maintenance documentation.
    • Plan, execute, and document the qualification of new laboratory equipment in a cGMP regulated environment, including writing equipment validation protocols and associated summary reports.
    • Conduct periodic reviews of instrument validation as part of validation life cycle.
    • Alert Quality Control Management in the event of equipment failing to meet calibration or qualification requirements and conduct impact assessments/investigations as required.
    • Schedule and coordinate equipment repairs and maintenance with vendors/contractors, minimizing downtime for lab equipment and disruption to laboratory activities.
    • Participate in technical project teams as subject matter expert on instrument validation regulations and procedures.
    • Own and project manage change controls and adherence to Change Control metrics where applicable.
    • Support and manage addition of project components to CMMS Maximo.
    • Act as key contributor and sponsor to Data Integrity Assessments for Lab systems.
    • Perform other tasks/projects assigned by manager.
  • Qualifications:
    • Bachelor's degree in Science related field is required.
    • Minimum 3 years of laboratory experience in cGMP laboratory environment including exposure to analytical instrument validation and data integrity assessments.
    • Detailed knowledge of methodology, instrumentation, and analytical techniques used for biopharmaceutical testing.
    • Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity.
    • Demonstrated success in managing equipment qualification or maintenance program advantageous.

Requirements

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