Quality & Laboratory

QC Senior Associate- QC Technical Services- Equipment Support
Level 4 : (12 Month Project)

Responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities. 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.

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.
• 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.
• Planning and conducting routine calibration, re-qualification 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

REQUIREMENTS

• Minimum of 3 years of 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.
• Demonstrated success in managing an equipment qualification or maintenance program advantageous.

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