Sr QC Associate Technical Services
Pharmaceutical Dublin Contract Mar 6, 2025
Overview
Responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities. Responsible for ensuring that all maintenance and calibration activities carried out by Calibration Technicians are tracked and managed through the Computerised Maintenance Management System (CMMS) Maximo. Must have specific hands-on laboratory equipment lifecycle and validation experience.
Key Responsibilities
Planning and conducting routine calibration, requalification and maintenance of laboratory equipment ensuring calibration and maintenance schedules are adhered to as per CMMS Maximo. Reviewing and filing of QC calibration and maintenance documentation.
Planning, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment, including the writing of equipment validation protocols and associated summary reports.
Conduct periodic reviews of instrument validation as part of validation life cycle.
Alerting Quality Control Management in the event of equipment failing to meet calibration or qualification requirements and conducting impact assessments/investigations as required.
Scheduling and coordination of equipment repairs and maintenance with vendors/contractors, while minimizing level of down-time for lab equipment, and disruption to laboratory activities.
Participation in technical project teams to act as a subject matter expert on instrument validation regulations and procedures.
Where applicable, owns and project manages change controls and adherence to Change Control metrics.
Supporting and managing the addition of project components to CMMS Maximo.
Act as a key contributor and sponsor to Data Integrity Assessments for Lab systems.
Any other tasks/projects assigned as per manager’s request.
Qualifications
Bachelor’s degree in a Science related field is required.
Minimum of 3 years of laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation and data integrity assessments.
Detailed 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.
Demonstrated success in managing an equipment qualification or maintenance program advantageous.
Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organizations throughout Ireland; for more information go to www.berkley-group.com.
If you would like to discuss this vacancy further or to discuss your career options in confidence, please call David O’Connell +353 (0) 86 126 3871 or send your cv to doconnell@berkley-group.com
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