Job Summary

Responsible for generating accurate results while following cGMP requirements. Responsible for analysing Dosage, Raw Material, Process and Cleaning Validation, Technology Transfer samples, using various chemical and instrumental techniques, in accordance with established compendia and in-house testing methods, while under minimum supervision. If required, responsible to review documentation for the QC department.

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.
• All other relevant duties as assigned, including tasks of a Chemist QS4.

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, other Microsoft Office Programs and laboratory software packages.
  • Strong knowledge of automated laboratory instrumentation such as HPLC, AA, UV, Dissolution, IR, UV/VIS Spectrophotometry and GC.
  • Excellent written and verbal English communication skills.
  • Knowledge of cGMP/cGLP.
  • Detail oriented with problem solving and instrument troubleshooting ability.
  • Strong organization and time management skills.
  • Excellent interpersonal skills.

• Technology/Instrumentation (Type & Complexity)
  • 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.

• Experience
  • Minimum of 1 year relevant experience in a pharmaceutical lab environment with Bachelor of Science degree.
  • Minimum of 2 years relevant experience in the analysis of pharmaceutical products with Community College diploma.