Laboratory Support Manager
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About the position
We are looking to identify a Laboratory Support Manager for an opportunity in Central Ireland to support the laboratory operations and assure regulatory compliant programs for a leading healthcare organisation.
Your primary responsibility will be to manage the team of engineers/scientists and 3rd party vendors who provide support to the various analytical groups on all aspects of analytical instrumentation and equipment including qualification, installation, maintenance, calibration and repair.
- Lead and manage a team of engineers/scientists on all instrumentation support projects for the laboratory analytical groups
- Oversee and manage all instrumentation support activities and projects
- Ensure all instrumentation support activities and projects are compliant with quality/QMP and documentation requirements
- Coordinates and performs calibration and maintenance activities on a range of analytical equipment.
- Coordinates and performs equipment qualifications, executing IQ/OQ/PQ activities.
- Reviews calibration and maintenance records from peers.
- Tracks and maintains equipment schedule.
- Reviews and updates equipment SOP’s.
- Trains analysts on equipment.
- Coordinate and prioritize project activities with internal functional groups analytical labs, QA, QC and facilities.
Education and Experience:
- Bachelor's degree in Science or related discipline
- Previous Supervisor/Management experience essential
- Experience working as a Scientist/Analyst within a GMP/Pharma environment where you had supervisory/management responsibility
- Previous experience that provides the knowledge, skills, and abilities to perform the job
Knowledge, Skills and Abilities:
- GMP knowledge and understanding of FDA, ICH, and USP guidelines
- Analytical equipment experience is a must. Experience in running/maintaining/calibrating a range of analytical equipment including HPLC/UPLC/Dissolution apparatus/ particle counting apparatus.
- Experience in biopharm equipment such as CE / ICE would be a plus.
- Ability to utilize Microsoft Excel and Word to perform tasks
- Proven ability in technical writing skills
- Proven problem solving and troubleshooting abilities
- Time management and project management skills
- Good written and oral communication skills
- Ability to work in a collaborative work environment with a team as well as working off own initiative.
- Ability to work in a fast paced environment requiring frequent changes in priorities.
- Ability to train/mentor junior staff.