QC Associate - Lab Equipment
PE Global is currently recruiting for Incoming QC Associate for a Client site in Dublin: QC Associate – QC Technical Services - Equipment Support. Overview: Responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities at client’s site. Responsible for managing & coordinating the schedules of Calibration Technicians & ensuring that all maintenance & calibration activities are tracked & managed through the Computerised Maintenance Management System (CMMS) Maximo. Responsible for 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. Key Responsibilities • 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. • Writing/contributing to equipment operating procedures and manuals. • 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. • Coordinating the audit of new vendors. • 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. • Capable of defending Lab systems validation and data integrity philosophy in an Audit situation. • Any other tasks/projects assigned as per manager’s request. Interested candidates should send their CV to Audrey.email@example.com or call 0214297900. This job originally appeared on RecruitIreland.com.
224 days ago