Chemist, PE

• 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.

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.

• Bachelor of Science in chemistry or related field.
• Minimum 3 years of experience in pharmaceutical analytical laboratory.

• Possess

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.