QC Analytical Chemist

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

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Job Summary

The Chemist Analytical QC QS4 carries out work related to quality control, stability, method transfer, validation, standard studies according to Standard Operating Procedure.

Job Responsibilities

• Must develop and demonstrate a basic understanding of test methods / SOPs / compendia and Certificates of Analysis. Proper labelling, inspection of 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. Making routine decisions around simple task priorities but governed strictly in their work by SOPs. Typically seeks the input of higher level team members in non-routine matters.
• Report all testing results and deviations encountered during testing. Utilizes basic analytical knowledge and experience in carrying out their assigned investigation activities.
• Proper documentation of analytical data and information. Self-reviews analytical data for accuracy and completeness. Under guidance, maintains records of retain, stability & standard samples and ensure that samples are properly stored.
• Under guidance, releasing of 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.
• Performs calibration of laboratory equipment according to the department’s calibration program. Reports all testing results and deviations encountered during the testing and inspection processes to their supervisor.
• Liaises with higher level laboratory personnel to learn the use of all applicable physical & chemical testing equipment and to acquire a fundamental understanding of departmental and regulatory practices. May liaise with other employees in departments across the organization.
• Demonstrates personal leadership attributes incorporating a commitment to ongoing professional development and continuous learning. Seeks performance inputs from peers, more senior team members and the supervisor to identify any performance gaps.
• 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

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

Conducts 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

At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer 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.