We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Daily management of the routine sample management operations/LIMS Stability Module.
Responsible for the management of stability inventory.
Ensure all activities follow SOP’s/WI’s and protocols where appropriate and are performed in compliance with regulatory guidelines.
Perform sample management activities according to local procedures and processes in a timely and organized fashion.
Organize stability inventory and maintain stability chambers.
Coordinate receipt and distribution of samples throughout the laboratories. Perform other duties as designated by Laboratory Management. Develop subject matter expertise on assigned role.
Use of laboratory software such as LIMS, SAP, SDMS, Trackwise, etc.
Contribute to proper use, calibration and maintenance of laboratory equipment.
Record all laboratory data in accordance with cGMP and local procedures.
Perform data review.
Keep up to date with existing and new SOP’s and official documentation.
Perform investigations, where required, for deviations, laboratory investigations etc.
Independently write/revise SOP’s or other official documentation and reports, when required.
Execute independently and/or as part of a team, assigned projects/tasks.
Train/coach other/new personnel.
Lead/participate in lean innovation and continuous improvement project
Responsible for coordinating activities in relation to laboratory batch release.
Responsible for coordinating activities in relation to clinical reference materials.
Responsible for coordinating activities in relation to stability programs.
Education & Experience
3rd level qualification in a science related discipline.
Knowledge of laboratory sample management and/or stability is preferred.
Industry experience (GMP laboratory) is essential.
Experience with LIMS systems is desirable.
Excellent attention to detail, good communication skills (written & verbal), ability to think logically, proactive approach, ability to work well within team structures, ability to work on own initiative.
Experience in statistical sampling plan development.
Experience in a biopharmaceutical or pharmaceutical plant start-up.