- 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 Empower administration queries
- Organise and assist as necessary with vendor or internal equipment calibrations.
- Coordinating & performing routine maintenance on and cleaning of laboratory equipment.
- 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.
- Dealing with client requests and liaising with the Team Leader in terms of resources, continuous improvement and ensuring continuity of service to the client.
- Coordinate, perform and review the shipment of samples externally for analysis.
- 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.
- To be constantly aware of the client’s requirements and strive to meet or exceed those requirements keeping in mind the client process and deliverables.
- To identify and communicate to Management and the client areas for improvement or optimisation in order to improve efficiencies and provide a cost-effective service. Actively participate in Lean and productivity improvement initiatives. Focus on continuous improvement and ability to propose and implement change.
- As with all members of staff this person is responsible for ensuring that the client requirements are fully met and in so doing will be flexible to work in any area of the business as is required.
Experience and 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 team player
- Good communication skills both internally and externally
- Accuracy, attention to detail
- Good organisation of work space and time management.
- Process improvement
For a confidential discussion and more information on the role, please contact Aisling on 021 4809118 or email firstname.lastname@example.org