Review data generated by another qualified analyst, when trained and formally authorized to perform independent verification, in accordance with applicable methods and procedures.
Participate in validation-batch testing, analytical method transfers, method verification and analytical validation activities.
Prepare, review and update technical documents, including analytical methods, specifications, Standard Operating Procedures, protocols and reports.
Participate in the management and periodic monitoring of chemical reagents, reference standards, HPLC columns, laboratory consumables and glassware.
Verify that reagents, standards, columns, instruments and equipment are suitable and within their approved status before use.
Support laboratory investigations related to atypical results, deviations, Out-of-Specification results and Out-of-Trend results by providing accurate data and factual technical input.
Maintain complete and traceable analytical records and promptly report any error, discrepancy, abnormal result or potential compliance concern to QC supervision.
Participate in laboratory housekeeping and 5S activities and maintain the cleanliness and appropriate status of the work area.
Follow Environmental, Health and Safety requirements and applicable laboratory safety procedures.
Complete assigned training curricula within the required timelines and maintain qualification for all assigned analytical activities.
Work collaboratively with Quality Assurance, Production, Supply/Warehouse, Engineering and Environmental, Health and Safety functions.
Contribute to continuous improvement activities within the Quality Control laboratory.
Must-Have
Bachelor’s degree or equivalent university degree in Chemistry, Analytical Chemistry, Pharmacy, Biology or another relevant scientific discipline.
Knowledge of Good Manufacturing Practices and Good Laboratory Practices.
Ability to understand and follow analytical methods, specifications, Standard Operating Procedures and technical instructions.
Analytical mindset with strong attention to detail and data accuracy.
Ability to work effectively in a team-based laboratory environment.
Good computer skills and ability to work with electronic laboratory and training systems.
Ability to communicate laboratory results, deviations and potential compliance concerns clearly and promptly.
Ability to work safely in a pharmaceutical Quality Control laboratory.
Previous experience in a pharmaceutical Quality Control laboratory.
Practical experience with HPLC, UV-Visible spectrophotometry, dissolution testing and other routine physicochemical testing techniques.
Experience with analytical method transfer, verification or validation.
Familiarity with chromatographic data systems such as Empower and enterprise or laboratory systems used for sample and material management.
Knowledge of Data Integrity and ALCOA principles.
Familiarity with Out-of-Specification, Out-of-Trend and laboratory investigation processes.
Experience with 5S, continuous improvement or IMEx ways of working.
Working knowledge of English and French.
Work Location Assignment: On Premise
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Quality Assurance and Control
