Collins McNicholas

Job Purpose:

The primary purpose of this role is to provide technical and analytical support tasks and to work to the highest standards in terms of quality and professionalism. 

Role Responsibilities:

  • Coordinate equipment qualification processes, including writing and progressing associated Change Control. Appropriately document all equipment management tasks in accordance with site procedures and ensure accurate records management. 
  • Coordinate and assist with the introduction of new equipment to the lab and the retirement of old equipment as required, administration of TAG numbers and SAP updates. 
  • Assist with Change Controls and document updates related to equipment management & lab support activities as needed. 
  • Coordinating & responding to ad-hoc requests for information and/or assistance relating to
  • administration queries 
  • Organise and assist as necessary with vendor or internal equipment calibrations. 
  • Coordinate, review and drive equipment management tasks carried out by others along with review of associated records. 
  • Coordinating & responding to ad-hoc requests for information and/or assistance relating to equipment management. 
  • Writing of SOPs related to area of work. 
  • Training, mentoring and guidance of the more junior team members to ensure understanding and competence in all tasks. 
  • Assisting the Team Leader in terms of scheduling, training plans, execution of training and ensuring routine tasks are completed on time, right first time. 
  • Maintaining all documentation and systems related to their work in collaboration with the client personnel and their suppliers. 
  • Participating in laboratory investigations as requested. 
  • Generation of certain quality and business-related metrics. 
  • Keeping their training records up to date and initiating training where possible when free from work. 
  • Adhering to all company standards in the area of safety, housekeeping and quality, notifying management of any discrepancies. 
  • Ensure that all documentation is carried out on time, accurately and legibly. 
  • Ensuring any quality or productivity issues within the team are investigated and dealt with appropriately, initiating CAPA as soon as appropriate. 

 

Experience / Skills Required:

  • At least 3 years GMP experience in a laboratory or e-system support environment is preferred 
  • Knowledge of and direct experience with laboratory e-systems (E.g. Empower 3) a distinct advantage. 
  • Change control (especially utilising Trackwise) and equipment qualification experience preferred. 
  • Good communication skills both internally and externally 
  • Accuracy, attention to detail 
  • Good organisation of work space and time management. 
  • Process improvement mindset

 

For a confidential discussion and more information on the role, please contact Aisling on 021 4809118 or email aisling.lane@collinsmcnicholas.ie

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