About Apotex Inc.
Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.
For more information visit: www.apotex.com.
Job Summary
The Chemist Analytical QC QS4 carries out work related to quality control, stability, method transfer, validation, and standard studies according to Standard Operating Procedure.
Job Responsibilities
- Develop and demonstrate a basic understanding of test methods/SOPs/compendia and Certificates of Analysis. Proper labelling, inspection, and sampling of finished products, intermediates, raw materials, recovered materials, etc. to ensure conformity with established standards.
- Testing of raw materials, intermediates, finished products, R&D Samples, environmental samples, etc. Performs physical testing of assigned packaging components, and physical and chemical testing of any samples according to requirements established in the test methods/SOPs/compendia and Certificates of Analysis.
- Report all testing results and deviations encountered during testing. Utilize basic analytical knowledge and experience in carrying out assigned investigation activities.
- Maintain proper documentation of analytical data and information. Self-review analytical data for accuracy and completeness. Under guidance, maintain records of retain, stability & standard samples and ensure proper storage.
- Under guidance, release finished products, intermediates, raw materials, and recovered materials upon approval of results by department management.
- Report problems related to instruments, methods, etc. to the Supervisor/Manager as quickly as possible.
- Keep the workplace clean, tidy, and safe.
- Under guidance, identify the need for chemicals, gases, standards, glassware, and other accessories.
- Perform calibration of laboratory equipment according to the department’s calibration program. Report all testing results and deviations encountered during the testing and inspection processes to the supervisor.
- Liaise with higher-level laboratory personnel to learn the use of all applicable physical & chemical testing equipment and acquire a fundamental understanding of departmental and regulatory practices.
- Demonstrate personal leadership attributes incorporating a commitment to ongoing professional development and continuous learning. Seek performance inputs from peers, more senior team members, and the supervisor to identify any performance gaps.
- Work 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 to 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
- Minimum B.Sc. in Chemistry or equivalent area of study.
- Knowledge, Skills and Abilities
- Familiar with cGMP
- Familiar with USP, BP, EP and ECH guidelines and procedures
- Knowledge of operating and troubleshooting instruments such as GC, HPLC, UV, IR
- Knowledge of wet analytical chemical techniques
- Ability to follow SOPs
- Conduct self in a manner consistent with safety fundamentals of a laboratory
- Documentation is neat and concise
- Participate in a shift rotation and/or on-call
- Knowledge of Windows, MS Office, Chemstore/Chemstation or suitable software
- Experience
- Preferable 1-2 years of experience in the related field of chemistry Education
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.