Senior QC Associate

AMC1234
Senior QC Associate
Contract – 12 months
Dublin
Senior QC Associate


Would you like to join a leading and biopharmaceutical company in Dublin, to further develop your career? This is an excellent opportunity to work on leading technologies in the biotech industry. As a QC Senior Associate, you willbe responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities.

To be successful in this role you must have a minimum of 3 years laboratory experience in cGMP laboratory environment including exposure to analytical instrument validation experience.


Responsibilities

• Managing & coordinating the schedules of Calibration Technicians & ensuring that all maintenance & calibration activities are tracked & managed through the Computerised Maintenance Management System (CMMS)
• 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.
• Commissioning of new laboratory equipment and facilities including developing lab equipment specifications
• Writing equipment validation protocols and associated summary reports.
• Conduct periodic reviews of instrument validation as part of validation life cycle.
• 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.
• Writing/contributing to equipment operating procedures and manuals.
• Designing and conducting training for QC staff, and other department staff as applicable
• Project manage Change controls and adhere to Change Control metrics.
• Periodic management updates on activities to senior management.
• Planning and conducting routine calibration, requalification and maintenance of laboratory equipment and ensure calibration and maintenance schedules are adhered to.

• 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.