Senior Laboratory Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €65,000 - €85,000
Quality Assurance Role

This is an exciting opportunity to join a leading biopharmaceutical company in Dublin. You will be working with cutting-edge technologies and contributing to the development of laboratory systems.

As a Senior QC Associate, you will be responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory equipment for cGMP Quality Control facilities.

Key Responsibilities:
  • Manage and coordinate schedules of Calibration Technicians, ensuring all maintenance and calibration activities are tracked and managed through CMMS.
  • Author and approve Validation Life Cycle documents for computer-related systems, including Data Integrity testing and business administration of Laboratory Computer Related systems.
  • Commission new laboratory equipment and facilities, including developing lab equipment specifications.
  • Write equipment validation protocols and associated summary reports.
  • Conduct periodic reviews of instrument validation as part of the validation life cycle.
  • Act as a subject matter expert on instrument validation regulations and procedures.
  • Serve as the point of contact with laboratory equipment vendors and engineers.
  • Coordinate equipment repairs and maintenance with vendors/contractors and carry out equipment maintenance as required.
  • Write/contribute to equipment operating procedures and manuals.
  • Design and conduct training for QC staff and other department staff as applicable.
  • Project manage Change controls and adhere to Change Control metrics.
  • Provide periodic management updates on activities to senior management.
  • Plan and conduct routine calibration, requalification and maintenance of laboratory equipment, ensuring calibration and maintenance schedules are adhered to.
Requirements:
  • Minimum of 3 years of laboratory experience in a cGMP laboratory environment, including exposure to analytical instrument validation.
  • Knowledge of methodology and 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 an equipment qualification or maintenance program advantageous.

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