Pharmaceutical Analyst, QC

2 months ago

Richmond Hill, Ontario, Canada Apotex Full time

About Apotex Inc.

Apotex Inc. is a leading global pharmaceutical company that specializes in the development, manufacturing, and distribution of high-quality, affordable medicines for patients worldwide. With a strong presence in over 75 countries, Apotex employs a diverse team of professionals in various fields, including research and development, manufacturing, and commercial operations.

Job Summary

The successful candidate will be responsible for generating accurate results while adhering to current Good Manufacturing Practices (cGMP) and regulatory requirements. This role involves analyzing various samples, including packaging materials, raw materials, and process validation samples, using advanced chemical and instrumental techniques.

Key Responsibilities

  • Perform analysis of packaging materials, labeling, raw materials, in-process, dosage, purified water, process, and cleaning validation samples using analytical instruments and established analytical procedures and techniques.
  • Compile all data obtained from testing and observations and complete report summaries, as per established Standard Operating Procedures (SOPs). Maintain accurate and complete records on all analysis performed.
  • Identify and report any Out-of-Specification (OOS) / Out-of-Trend or Questionable results or any issues of non-conformance to the supervisor immediately. Assist in the completion of laboratory investigations under the direction of the supervisor.
  • Perform daily calibration of laboratory equipment, such as balances, pH meters, 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 the Quality Control department.
  • Maintain compliance with all health and safety standards, current Good Manufacturing Practices, current Good Laboratory Practices, and regulatory requirements. Be 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).
  • Provide technical troubleshooting support or training to other team members as needed.
  • Perform all work in accordance with established regulatory and compliance and safety requirements.
  • Dispose of waste solvents and order chemicals or laboratory supplies as required.
  • Chemists may be trained to work in cross-functional areas within Quality Control.
  • Work in a safe manner, collaborating as a team member to achieve all outcomes.
  • Demonstrate behaviors 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.
  • Perform all other relevant duties as assigned.

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, 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:
    • UV, FT-IR, Karl Fischer Water Tester, pH meter, TOC analyzer, 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.

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