Lab Support Manager - Metrology
This succesful pharmaceutical company in the midlands is looking for a Lab Support Manager at their Westmeath site to support the laboratory operations and assure regulatory compliant programs.
Your primary responsibility will be to manage the team of engineers/scientists and 3rd party vendors who provide support to the various analytical groups within the company, on all aspects of analytical instrumentation and equipment including qualification, installation, maintenance, calibration and repair.
• Lead and manage a team of 4-6 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 per PPD procedures.
• Coordinates and performs equipment qualifications, executing IQ/OQ/PQ activities.
• Reviews calibration and maintenance records from peers.
• Tracks and maintains equipment schedule per internal procedures.
• 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
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience.
• Experience working as a Scientist/Analyst within a GMP/Pharma environment where you had supervisory/management responsibility
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.
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