Highly Skilled Laboratory Professional Wanted

3 days ago

Dublin, Dublin City, Ireland beBeeQuality Full time €60,000 - €80,000
Quality Control Specialist

We are seeking a highly skilled Quality Control Specialist to join our team. This is an excellent opportunity to work on leading technologies in the biotech industry.

Job Summary:

The successful candidate will be responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities.

Key Responsibilities:

  • Managing and coordinating the schedules of Calibration Technicians and ensuring that all maintenance and calibration activities are tracked and managed through the Computerised Maintenance Management System (CMMS).
  • Authoring/owning and approving Validation Life Cycle documents for computer related systems including responsibility for Data Integrity testing and business administration of Laboratory Computer Related systems.
  • Commissioning of new laboratory equipment and facilities including developing lab equipment specifications.
  • Writing equipment validation protocols and associated summary reports.
  • Conduct periodic reviews of instrument validation as part of validation life cycle.
  • Act as a subject matter expert on instrument validation regulations and procedures.
  • Serving as the point of contact with laboratory equipment vendors and engineers.
  • Coordination of equipment repairs and maintenance with vendors/contractors and also carrying out equipment maintenance as required.
  • Writing/contributing to equipment operating procedures and manuals.
  • Designing and conducting training for QC staff, and other department staff as applicable.
  • Project manage Change controls and adhere to Change Control metrics.
  • Periodic management updates on activities to senior management.
  • Planning and conducting routine calibration, requalification and maintenance of laboratory equipment and ensure 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 the methodology and instrumentation and analytical techniques used for biopharmaceutical testing.
  • Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity.

What We Offer:

An exciting opportunity to work in a dynamic and innovative company. As a Quality Control Specialist, you will have the chance to develop your skills and expertise in a challenging and rewarding role.

Contact Information:

If you meet the minimum requirements and feel this is the right role for you, please submit your application today.

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