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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Senior QC Specialist - Equipment & Instrumentation


Reference:RK5368 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: EHS Specialist, Quality Engineer

Senior QC Specialist -Equipment & Instrumentation
Hybrid
RK5368
Contract 12 months
Dublin



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



This role is responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities and for ensuring that all maintenance & calibration activities carried out by Calibration Technicians are tracked & managed through the Computerised Maintenance Management System (CMMS) Maximo.



Duties:

  • Planning and conducting routine calibration, requalification and maintenance of laboratory equipment ensuring calibration and maintenance schedules are adhered to as per CMMS Maximo. Reviewing & filing of QC calibration & 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 CMMA Maximo
  • Act as a key contributor and sponsor to Data Integrity Assessments for Lab systems
  • Any other tasks/projects assigned as per manger’s request



Educational and Experience
  • 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.
  • Hands-on laboratory equipment lifecycle and validation experience
  • 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.


If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.