Our client a leading pharmaceutical company is Cork is looking into hire an Associate Scientist for their site on a contractual basis.
Global Clinical Release & Stability is a department of Discovery, Product Development and Supply; BioTherapeutics Analytical Development – (DPDS, BioTD-AD).
The department is responsible for Tox Release testing, Clinical Release and Stability Testing for Drug Substance and Drug Product, and Stability Lifecycle management.
Main duties and responsibilities for this role
Responsible for coordinating sample receipt, logging of release and stability studies, distribution and shipping of samples as well as inventory management activities in accordance with GLP practices.
Including, but not limited to:
- 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.
- Record all laboratory data in accordance with cGMP and local procedures.
- Keep up to date with existing and new SOP’s and official documentation.
- Daily management of the routine sample management operations.
- Develop subject matter expertise on assigned role.
- Use of laboratory software such as LIMS, SAP, SDMS, Trackwise, etc.
- 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
- Perform other duties as designated by Laboratory Management.
- A third level qualification of a scientific/technical discipline is required.
- 2+ years’ experience in a similar role
- Knowledge of laboratory sample management and/or stability material is preferred.
- Industry experience (GMP laboratory) is desirable.
- Experience with LIMS systems is desirable.
- Key Skill Requirements: excellent attention to detail, good communication
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