Chemist, PE

Job Summary

• Responsible for testing of Raw Materials, In-Processes, Finished Products and Stability Samples. Work together with AD department to performing co-validation for analytical test methods. Provide audited stability summary report for submission. Prepare and update stability schedule for various drug products.

• Responsible and accountable for compliance with all aspects of the Ontario Occupational Health and Safety Act, Safe Work Procedures (SWPs) as well as Apotex’s Health, Safety and Environmental policies.
• Responsible and accountable for compliance with all aspects of the Apotex SOP’s and cGMP requirements.

Job Responsibilities

• Under minimum supervision perform analysis of raw materials, In-processes, finished products and stability samples with high degree of accuracy and precision using analytical instruments and established analytical procedures.
• Document results clearly in accordance with SOP’s
• Provide statistical analysis on test results as required.
• Organize work efficiently and utilize time effectively.
• Communicate technical information in a clear and concise manner, both verbally and in written form.
• Under supervision, perform intermediate precision as part of method transfer in conjunction with AD method validation.
• Other responsibilities as assigned by the supervisor.

Technology/Instrumentation (type & complexity)

• 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.
• In addition, more complex techniques as required.

Experimental or Methodological Design (if applicable)

• Review specifications, test procedures and SOP’s prior to use and provide feed - back as required.

Relationship with Internal/External Customers & Stakeholders

• Act as key player within the team and help senior chemist when difficult task is performed.
• Liaise regularly with their internal customers to understand their needs and keep them current with work progress.

Problem Solving Analysis

• Solve routine problems independently
• Identify complex problems with instruments, specifications and test methods and report them to the senior level for corrective action.

Decision Making/Autonomy

• Respond to queries from junior chemist and participate in training new staff if required.

Leadership/Professional Development of Self & Others

• Continually upgrade their technical knowledge by attending seminars or taking appropriate courses.

Compliance & Due Diligence

• Perform all activities in compliance with SOP’s, cGMP and SHE
• 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.
• Possess

(a) Laboratory computer skills

(b) Operational and good trouble shooting skills related to analytical instruments.

(c) Good knowledge of GMP, GLP and WHMIS.

(d) Good knowledge of pharmaceutical compendia.