Position: Analyst, Development, Validation and Analytical Support
Location: Montreal
Perks: RRSP, Insurance and Competitive Vacation
Job Summary
This position is responsible for the development, optimization, and validation of analytical methods. The analyst will also be responsible for writing and executing validation protocols, writing method validation and transfer reports, and training Quality Control analysts on new methods. In addition, the analyst will provide support to Quality Control in case of analytical problems and participate in the analysis of various products developed by the Research and Development department.
Responsibilities
- Participate in the development of project timelines
- Develop/improve analytical methods in accordance with regulatory requirements while respecting Good Laboratory Practices (GLP)
- Verify methods of recognized pharmacopoeias
- Find solutions to problems related to current analytical methods
- Write and execute analytical method validation or transfer protocols
- Write and revise method validation or analytical technical transfer reports
- In collaboration with the R&D group, verify and propose analytical methods for ingredients and products developed
- Collaborate on investigations of out-of-specification (OOS) anomalies
- Perform qualification analyses of different raw materials and finished products
- Train analysts on analytical methods
Qualifications
- Bachelor's degree in chemistry, biochemistry or other relevant field of study
- Minimum of 5 years of experience in the pharmaceutical industry in method development and validation
- Experience with various techniques: HPLC, GC, FTIR, Atomic Absorption, Dissolution, etc.
- Good understanding and application of Good Laboratory Practices (GLP) and applicable regulatory requirements
- Excellent writing skills and technical rigour required
- Excellent analytical skills
- Keen sense of planning and organization
To apply, please send your resume to Maia Slivinschi at maia.slivinschi@quantum.ca.
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