Global Biotechnology company based in south Dublin, IRL - looking for Sr Associate QC (Senior).
The successful candidate will be responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities, ensuring that maintenance and calibration activities carried out by Calibration Technicians are tracked and managed through the Computerized Maintenance Management System (CMMS) Maximo and that Validation Life Cycle documents for computer related systems are authored, owned and approved, including Data Integrity testing and business administration of Laboratory Computer Related systems.
Responsibilities
Planning and conducting routine calibration, re-qualification 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.
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, instrumentation and analytical techniques used for bio-pharmaceutical 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.
The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.
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