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Details

Senior QC Associate - Equipment Support


Reference:SMC028622 Location: Dublin
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Nurse Associate, QC Analyst

Summary

We’re currently recruiting for an exciting opportunity with an award winning Pharmaceutical organization based in Dublin. This is an excellent opening for anyone who is looking to join a leading multinational who are one of the best at what they do. The successful candidate will be responsible for managing & coordinating the schedules of Calibration Technicians & ensuring that all maintenance & calibration activities are tracked & managed.

Duties

• Planning, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment.
• Developing and maintaining an equipment qualification project plan, as part of the commissioning of new laboratory facilities.
• Relocation of existing equipment to new Chemistry laboratory.
• Development of laboratory equipment specifications to be used for procurement of new laboratory equipment and instruments.
• Writing equipment validation protocols and associated summary reports.
• Maintaining a current working knowledge with regard to regulatory requirements for equipment qualification and calibration.
• Generation and resolution of protocol discrepancies as required.
• Alerting Quality Control Management in the event that equipment fails to meet calibration or qualification requirements, and conducting impact assessments/investigations as required.
• Participation in technical project teams in order to 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.
• Scheduling of repairs and maintenance in order to minimize level of down-time for lab equipment, and disruption to laboratory activities.
• Designing and conducting training for QC staff, and other department staff as applicable.
• Owns and project manages change controls and adhere to Change Control metrics.
• Preparing and presenting periodic management updates on activities to senior management.
• Conduct periodic reviews of instrument validation as part of validation life cycle.
• Planning and conducting routine calibration, requalification and maintenance of laboratory equipment and ensure calibration and maintenance schedules are adhered to as per CMMS Maximo.
• Reviewing & filing of QC calibration & maintenance documentation.
• Development of laboratory equipment specifications to be used for procurement of new laboratory equipment and instruments.
• Recognised as System Owner & Business Administrator for QC Equipment.
• A key contributor to Data Integrity Assessments for Lab systems

Knowledge & Experience

• 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.



If you would like further Information you can contact the recruiter directly:

Sean McCarthy | Tel: +353 (0) 87 798 8480