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Chemist, Research and Development
2 months ago
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
- Responsible for conducting analytical testing of raw materials, in-process materials, finished products, and stability samples to ensure compliance with regulatory requirements and company standards.
- Collaborate with the analytical development department to develop and validate analytical test methods, ensuring accuracy and precision.
- Prepare and submit stability summary reports to regulatory authorities and internal stakeholders.
- Develop and maintain stability schedules for various drug products, ensuring timely and accurate reporting.
Key Responsibilities
- Under minimal supervision, perform analytical testing using various instruments and established procedures, ensuring high accuracy and precision.
- Document test results clearly and accurately, adhering to standard operating procedures (SOPs) and regulatory requirements.
- Provide statistical analysis of test results as required, ensuring timely and accurate reporting.
- Organize work efficiently, utilizing time effectively to meet deadlines and ensure compliance with regulatory requirements.
- Communicate technical information clearly and concisely, both verbally and in written form, to internal stakeholders and regulatory authorities.
- Perform intermediate precision testing as part of method transfer, under supervision, to ensure accuracy and precision.
- Other responsibilities as assigned by the supervisor, including participating in training and development programs to enhance technical knowledge and skills.
Technical Requirements
- Sound working knowledge of UV-VIS spectrophotometer, Karl Fisher, Auto-titrator, HPLC, GC, IC, balances, vacuum oven, microscope, osmometer, density meter, Hunter scan, and Auto-actuation station.
- Ability to operate complex analytical instruments and techniques as required.
Relationship with Internal/External Customers & Stakeholders
- Act as a key player within the team, providing technical expertise and support to senior chemists and other stakeholders.
- Liaise regularly with internal customers to understand their needs and provide timely updates on work progress.
Problem Solving Analysis
- Solve routine problems independently, utilizing technical knowledge and skills to resolve issues.
- Identify complex problems with instruments, specifications, and test methods, and report them to senior-level personnel for corrective action.
Decision Making/Autonomy
- Respond to queries from junior chemists and participate in training new staff as required, demonstrating technical expertise and leadership skills.
Leadership/Professional Development of Self & Others
- Continuously upgrade technical knowledge by attending seminars, workshops, and training programs, staying up-to-date with industry developments and best practices.
Compliance & Due Diligence
- Perform all activities in compliance with SOPs, cGMP, and SHE policies, ensuring adherence to regulatory requirements and company standards.
- Participate in reviewing department policies, procedures, and standards impacting their area, as required.
Job Requirements
- Bachelor of Science in chemistry or related field.
- Minimum 3 years of experience in pharmaceutical analytical laboratory.
- Operational and good trouble-shooting skills related to analytical instruments.
- Good knowledge of GMP, GLP, and WHMIS.
- Good knowledge of Pharmaceutical compendia.
