- June 12, 2017
- Develop, validate and document new analytical methods with minimum supervision.
- Prepare development/validation, protocols and other research reports.
- Report and clearly document all research work performed.
- Report GMP work in accordance with current GMP/GLP regulations.
- Participate in activities leading to product approval (i.e. deficiency letter responses for chemistry issues, investigations, etc., with specific tasks outlined by the Manager).
- Testing of R&D batches, raw materials and packaging components in accordance with GMP/GLP regulations may be required as needed
- Provide analytical and technical support to R&D Analytical Chemists and Production Development Chemists
- Assist the Analytical Chemists with out-of-spec investigations.
- Participate in the training/coaching of new staff.
- Isolate/identify/synthesize impurities as required.
- Evaluate spectroscopic data (NMR, MS, IR).
- Research and prepare product and packaging material specifications.
- Maintain a clean laboratory environment and ensure that safety regulations are followed.
- Complete all GMP Documentation correctly and in a timely manner.
- Complete all training assignments and maintain personal training records.
- Participate in and/or lead Non Conformance Investigations.
- Complete Corrective and Preventative Actions (CAPA’s).
- Initiate and follow through with actions required to close Change Controls.
- Participate in the training / coaching of new staff.
- Participate in Internal, Customer and Regulatory Audits.
- Work is completed with little supervision/guidance in a timely manner.
- Other duties as assigned.
- B. Sc. in Chemistry or related pharmaceutical discipline. M.Sc. or Ph.D. degrees in Chemistry are preferred.
- Minimum 5 years’ experience in a pharmaceutical R&D environment.
- Superior theoretical and practical knowledge of organic, inorganic and analytical chemistry including in-depth knowledge of gas and liquid chromatography, spectrography and other analytical techniques employed in pharmaceutical development.
- Sound theoretical and practical knowledge of chromatography and spectrography
- Strong knowledge and understanding of GMP-s and GLP-s, as well as with pertinent FDA and Health Canada guidelines
- Excellent written and verbal communication skills,
- Ability to communicate and work effectively in a team-based environment
- Knowledge of applicable software
- Good organizational skills; Multi-tasking ability
** Career Connections Canada Inc. welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. To request an accommodation, please contact Career Connections Canada Inc..
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