Posted: 18 June
The role
Associate Scientist
Location: Cork
Duration: 12 months
Hours: 39
Global Clinical Release & Stability is a department of Discovery. Product Development and Supply; Therapeutics Development & Supply Analytical Development – (DPDS, TDS-AD). The department is responsible for Clinical Release and Stability Testing for Drug Substance and Drug Product, and Stability Lifecycle management.
Roles and Responsibilities
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.
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, COMET, 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 projects.
How to Succeed
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.
Key Skill Requirements: 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.
Benefits
This role offers a very competitive hourly rate. This contract will run for 12 months.
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