Sr Associate QC Senior 28622a

Independent Solutions

Dublin

Job Title Sr Associate QC Senior 28622A. About Company Our client based in Dun Laoghaire is seeking aSr Associate QC Senior to join its expanding team. Duration of role 12 months. Summary Objective 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. Job 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. • 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. This job originally appeared on RecruitIreland.com.

1878 days ago