Chemist, QC QS5

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.

Job Responsibilities

• Perform analysis of Raw Material, Purified Water, In-process, Dosage, Process and Cleaning Validation and Technology Transfer using analytical instruments and established analytical procedures and techniques as scheduled within the established departmental testing timelines.
• Interprets and documents all test results, calculations and observations and completes report summaries, as per established SOP.
• Identifies and reports any Out-of-Specification (OOS) / Out-of-Trend (OOT) 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.
• Works as an effective team member to meet departmental goals and initiatives, sharing knowledge with team members and across QC.
• Troubleshoots instrumentation and method problems with the supervisor’s assistance.
• 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. Uses knowledge of cGMP to assess impact on compliance and obtains supervisors assistance.
• Disposes of waste solvents and orders any chemicals or laboratory supplies as required.
• Performs role of Document Reviewer, if qualified as outlined below :
• Ensures accurate results that conform to current specifications, according to Current Good Manufacturing Practices, in-house, compendia and regulatory requirements, and verifies all calculations for mathematical and analytical accuracy.
• Liaises with department chemists to ensure that all necessary corrections are made to analytical reports and document requirements to ensure compliance to cGMPs.
• Reviews calibration of instruments, as assigned, to ensure accuracy and precision in the performance of laboratory equipment.
• Perform SAP results recording, if required.
• Performs all work in accordance with all established regulatory and compliance and safety requirements.
• 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.

Job Requirements

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

OR

Knowledge of Excel, Word, other Microsoft Office Programs and laboratory software packages.

UV, FT-IR, Karl Fischer Water Tester, pH Meter, TOC analyzer, HPLC, UV, Dissolution, Titration, Fluorimetric, Column Chromatography, Auto-Titrator, Viscometer, TLC, AA, GC, DSC, Melting Point, Particle Size Laser.

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.

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