We are recruiting, on behalf of our client, an experienced stability Specialist to strengthen the team. This opportunity is a temporary contract.
Main purpose of the role:
The stability specialist is responsible for the stability sample management.
This includes the ability to initiate stability study, Labeling & staging into stability chambers, remove samples at the define time points.
· Responsible for the handling of commercial stability program for internal products:
- batch selection,
- LIMS setup,
- samples inventory, labeling,
- samples pull,
- coordination with QC, etc.….
· Write stability protocols and others related documents
· Perform data verification as needed
· Organize the stability chambers cleaning and maintenance.
· Capability of solving problems with a minimum guidance
· B.S. Chemistry, Biology, Microbiology or relevant discipline
· 1-3 years of relevant work experience required in a Pharmaceutical environment
· Previous experience in conducting stability studies is preferred
An equivalent combination of education and experience may substitute
· Good understanding of pharmaceutical regulatory requirements such as ICH guidelines and their impact to commercial laboratory
· Good knowledge in stability study guidelines and cGMP
· Knowledge of LIMS software, Labware is preferred
· Advance written and verbal communication skills
· Ability to set priorities to meet timelines
· Ability to work independently
· Intermediate knowledge of Microsoft Word, Outlook, and Excel
· Advanced knowledge in English and French