LSC have a great contract opportunity for a QC Shared Services Instrumentation Senior Specialist to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life.
If you have 3+ years of experience working within a GMP laboratory environment, including laboratory instrument qualification experience, and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
* Provide calibration and maintenance support to QC laboratories, including scheduling and tracking instrument maintenance and managing the laboratory instrument lifecycle.
* Review and approve analytical instrumentation qualification, calibration, repairs and associated documentation.
* Manage instrument-specific investigations, including calibration deviations, and trend instrument performance to support effective lifecycle management.
* Support the purchase, installation and qualification of new laboratory instrumentation.
* Work collaboratively with QC Specialists, QA Validation Specialists and Computer System Validation personnel to deliver the qualification of new instruments.
* Liaise with vendors and sister sites on instrumentation purchase, qualification and lifecycle management while ensuring compliance with GMP, corporate policies and current regulatory requirements.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
* Minimum B.Sc. in a scientific or related discipline with at least 3 years' experience in a GMP laboratory environment, including at least 1 year of laboratory instrument qualification experience.
* Strong experience in laboratory instrumentation management, calibration, maintenance and qualification, with knowledge of biopharmaceutical analytical platforms such as HPLC/UPLC, CE, cIEF, SDS-PAGE, Biacore, HIAC, KF and Liquid Handlers.
* Strong organisational, communication and teamwork skills with the ability to manage multiple priorities; experience with Data Integrity requirements (21 CFR Part 11/EU Annex 11) and technology transfer would be advantageous.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Kathy Gillen on 021 4777329 if you have any more questions about this role!
