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.
- 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 firstname.lastname@example.org
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