Responsible to generate accurate results while following GMP requirements. Responsible for analysing packaging material, Finished product raw material samples and process validation and optimisation samples, using various chemical and instrumental techniques, in accordance with established compendial and in-house testing methods, while under minimum supervision.
Perform analysis of packaging material, labeling, raw material, in-process and finished products, purified water, cleaning validation and stability samples using analytical instruments and established analytical procedures and techniques.
Compiles all data obtained from testing and observations and completes report summaries, as per established SOPs. Maintain accurate and complete records on all analyses performed.
Recognises OOS or out of trend results and under the direction of the Supervisor assists in the completion of lab investigations.
Performs calibration of laboratory equipment as required by the department's established calibration program and GMP requirements.
Work as an effective team member to meet departmental goals, sharing knowledge with team members and across CLO.
Maintains compliance to all health and safety standards, Good Manufacturing Practices, Good Laboratory Practices and regulatory requirements. Responsible and accountable for compliance with all aspects of the Ontario Occupational Health and Safety Act, as well as Apotex’s Health and Safety policies, and Safe Work Procedures (SWPs).
Provides technical troubleshooting support or training to other team members where appropriate.
Disposes of waste solvents and orders any chemicals or laboratory supplies as required.
Critique specifications and methods as observed during testing and provide feedback.
Introduction to reviewing analytical documentation for analysis performed by other chemists under coaching from a senior member.
Performs additional related duties as assigned by the supervisor and manager.
B.Sc. from a recognized educational institution in Chemistry or a related field;
Community College diploma in a related field and a minimum of 1 year of relevant experience in the analysis of pharmaceutical products.
Knowledge of Excel, Word and other Microsoft Office Programs.
Good theoretical understanding of FT-IR, titration, UV and chromatography (TLC and column).
Excellent verbal and written English communication skills.
Knowledge of GMP/GLP.
Problem solving ability.
Proven organization and time management skills as demonstrated through previous work and/or educational experience.
Technology/Instrumentation (type & complexity)
UV, FT-IR, Karl Fischer Water Tester, TOC analyser, HPLC, disintegration, UV dissolution titration, fluorimetric, bulk and sieve analyses, column chromatography, auto-titrator, viscometer, TLC, melting point, Particle Size Laser.
Calibrates lab equipment such as balance, disintegration, FT-IR, Karl Fischer titrator, pH meter and UV according to established calibration program and GMP requirements. Apotex - 22 months ago