The department is responsible for Tox Release testing, Clinical Release and Stability Testing for Drug Substance and Drug Product, and Stability Lifecycle management.
- Responsible for coordinating sample receipt, distribution and shipping of samples as well as inventory management activities in accordance with GLP practices.
- Complete logging of samples for release and stability testing.
- Complete stability pulls as per defined schedules.
- Complete logging of samples for distribution.
- 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.
- Responsible for the management of stability inventory.
- Organize stability inventory and maintain stability chambers.
- 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.
- 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.
- 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 skills (written & verbal), ability to think logically, proactive approach, ability to work well within team structures, ability to work on own initiative.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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The Life Science Specialists