IPC Laboratory Leader

Thermo Fisher Scientific Cork, Cork

About the Job

The purpose of this job is to co-ordinate the testing activities within the IPC laboratory thereby ensuring that internal and external customer requirements are met.

Team Management

  • Participate in identifying resource requirements (personnel, equipment and facilities) for the IPC laboratory. Participate in the recruitment of personnel for the laboratory and develop the strengths/talent of team members.
  • Ensure that group and individual training requirements are met. This should be done through building relationships in conjunction with relevant regular team meetings. Foster enthusiasm / teamwork within the respective groups and recognise and reward achievement. Address poor performance issues.
  • Liaise with the Operations team and other customers to ensure all IPC testing requirements are met.
  • Highlight operational issues to the quality leadership team.
  • Liaise with internal customers to establish workloads, agree timelines (where appropriate) and identify priorities. Manage and prioritise the activities of the IPC laboratory such that customer, team and individual objectives are met. Ensure that Visual Workplace metrics and Performance Management for the laboratory are achieved.

Provide management with regular communications regarding IPC Visual Workplace metrics, Performance Management, specific project work or other initiatives within the IPC group

Lead/Participation in Cross Functional Teams

  • Lead/participate as required in cross-functional teams (internal & external). Ensure that the views of the laboratory are represented.
  • Track and ensure the timely completion of actions assigned and that project milestones are achieved. Communicate outputs/milestones to management where appropriate.
  • Co-ordinate the implementation of recommendations/ agreements for the laboratory.
  • Work to incorporate GPS Principles into the laboratory.

GMP/Compliance

  • Promote good laboratory GMP. This should include a review of housekeeping/GMP Audits to ensure that corrective actions have been completed.
  • Ensure that all team members have a working knowledge of all relevant site and analytical Standard Operating Procedures.
  • Ensure calibration of equipment is carried out as per the documented schedule.
  • Ensure that environmental water testing is carried out as per defined schedule.
  • Maintain Reference Materials stocks as appropriate.
  • Ensure completion of any corrective actions assigned to the laboratory as part of a level 2 audit.
  • Carry out monthly review of Laboratory Investigation Reports for the laboratory.
  • Monitor rejection of invalid data reports on a monthly basis.
  • Ensure there is a process for the Review of Cleaning Batch Records, Solvent Recovery Batch Records as required.
  • Maintain Laboratory Raw Data books in compliance with GMP requirements.
  • Communicate any outstanding quality issues to the QC manager as appropriate.
  • Prepare and support Quality group for internal and external audits.
  • Promote and support safety within the laboratory. Ensure all laboratory activities are carried out in compliance with safety Standard Operating Procedures (SOP’s) and site policies and investigate and report all near misses/accidents, which occur. Ensure corrective action(s) arising from safety audit/incident investigations are undertaken and completed in a timely manner.
  • Provide oversight and review for laboratory investigations.
  • Review and approval of change controls
  • Review and approval of GMP documentation eg equipment qualification, procedures, protocols/reports etc

  • Auditing

    Execute Level 1 and Level 2 audits as required