Sr Associate QC

Team Horizon is seeking a Sr Associate QC (Senior) for our client in Dublin.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
  
  
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
  
  
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.
  
  What you will be doing:
  
  
• Planning and conducting routine calibration, requalification 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.
  
  
• 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
  
  
• Any other tasks/projects assigned as per manager’s request
  
  What you need to apply:
  
  
• 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