Description
Our client, a Canadian pharmaceutical company with fully integrated infrastructures for R&D, manufacturing, distribution, and marketing, is looking for a Quality control analyst for their laboratory.
Their vast product line includes innovative and generic products as well as over-the -counter products. Their products are also exported to several countries around the world.
The position relies heavily on comprehensive wet chemistry techniques, dissolution, HPLC and UV testing on raw materials, in-process, final products and stability samples per established SOPs and pharmacopoeia product specifications.
As a QC analyst you will be :
- Performing tests for Certification of Analysis of Raw Material, Finished Products and Stability Samples
- Documenting and reporting results in accordance with GMP and GLP
- Participate in method validation protocol and reports in a timely manner with accuracy and precision in compliance with laboratory SOPs, product specifications, and regulatory guidelines
- Participate in method development and method validation / verification for API and finished products
- Participate in the resolution of issues with respect to laboratory analysis and laboratory instrumentation
- Performing all work in accordance with all established regulatory, compliance and safety requirements
- Conducting investigation of unexpected issues in developmental and regular products as directed and provides solutions to resolve the findings
- Revising and updating existing methods when required
- Participating in the development and / or providing recommendations for department SOPs and procedures
Education and competencies :
- Education : Master or Bachelor in Science, major in Chemistry
- Experience : Minimum of 3 years Quality Control experience in the Pharmaceutical industry
- Specialized Training : Good knowledge and understanding of GMP, GLP, analytical techniques and method validation.
- Sound theoretical and technical knowledge of chromatographic sciences and spectroscopic technologies such as UV, IR, GC, HPLC, LC-MS, AA, TOC, etc.
- Sound understanding of current GMP, ICH and FDA requirements
- Excellent organizational skills to meet frequent changes in immediate priorities, problem solving skills, and understanding of various computer software programs required
- Excellent oral and written communication skills in English and French
- Willing to work in a team-based environment
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