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QC Associate Lead
2 weeks ago
A Senior Laboratory Associate is required to join a leading multinational organization in Dublin. This role involves planning, executing and documenting the qualification, calibration and maintenance of laboratory systems in a cGMP Quality Control environment.
Key Responsibilities:
- Planning and conducting routine calibration, requalification and maintenance of laboratory equipment ensuring calibration and maintenance schedules are adhered to as per CMMS Maximo.
- Reviewing and 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.
Requirements:
- 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, 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.
About Us
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.
