Chemist, QC

About Apotex Inc.

Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: www.apotex.com .

Job Summary

Responsible for generating accurate results while following cGMP requirements. Responsible for analyzing Packaging Material, Dosage, Raw Material samples and Process Validation samples, using various chemical and instrumental techniques, in accordance with established compendia and in-house testing methods, while under minimum supervision.

Job Responsibilities
Perform analysis of Packaging Material, Labelling, Raw Material, In-process, Dosage, Purified Water, Process and Cleaning Validation 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 analysis performed.
Identifies and reports any Out-of-Specification (OOS) /Out-of- Trend or Questionable results or any issues of non-conformance to Supervisor immediately. Under the direction of the Supervisor assists in the completion of lab investigations.
Performs Daily calibration of lab equipment such as balance, pH meter and Milli-Q Water in accordance with established procedures.
Work as an effective team member to meet departmental goals and initiatives, sharing knowledge with team members and across QC.
Maintains compliance to all health and safety standards, Current Good Manufacturing Practices, Current 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.
Performs all work in accordance with all established regulatory and compliance and safety requirements.
Disposes of waste solvents and orders any chemicals or laboratory supplies as required.
If required, Chemists are trained to work in cross functional areas within QC.
Works in a safe manner collaborating as a team member to achieve all outcomes.
Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
All other relevant duties as assigned.

Job Requirements
Education

Bachelor of Science from a recognized educational institution in Chemistry or a related field;

OR

Community College diploma in a related field Knowledge, Skills and Abilities
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 cGMP/cGLP.
Problem solving ability.
Strong 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, pH meter, TOC analyser, HPLC, UV, Dissolution, Titration, Fluorimetric, Column Chromatography, Auto-Titrator, Viscometer, TLC, Melting Point, Osmolality, Particulate Matter, Density, Seal Integrity, Particle Size Laser.
Experience
Minimum of 1 year of relevant experience in the analysis of pharmaceutical products.

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.