Chemist, QC QS4-GQC-DOSRH R

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.

• 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.

• 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.