Apotex Inc.
About Apotex Inc.
Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: www.apotex.com .
Job Summary
Generate stability program for all development products.
Test In-Process, Finished Product, Raw Material and Stability Samples.
Provide audited stability summary report for submission.
Work together with AD department to performing intermediate precision for analytical test methods.
Prepare and update stability schedule for various drug products.
Job Responsibilities
Responsible for testing of Stability Samples, Raw Materials, In-Processes, Finished 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 to ensure compliance of team members (direct reports) with Safety and Employment policies (e.g., Respect in the Workplace – Prevention of Violence and/or Harassment).
Works as a member of a team to achieve all outcomes.
Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.
Performs all work in accordance with all established regulatory and compliance and safety requirements.
All other duties as assigned.
Working knowledge of testing in LIMS.
Work independently in performing 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
Generate statistical analysis on test results as required.
Provide support to investigate “Out-of-Specification” or “Out-of-Trend” results. Organize time effectively and demonstrate a strong ability to plan their projects.
Communicate effectively with others and build constructive relationship within groups.
Other responsibilities as assigned by the supervisor.
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.
Review specifications, test procedures and SOP’s for their deficiencies and recommend solutions to the next level.
Act as key player within the team and acquires a more understanding of the customer’s needs in order to meet short and long-term deliverables.
Identify problems with instruments, specifications and test methods and is proactive in effecting a solution.
Utilize advanced problem solving techniques to identify the root cause and determine the course of action.
Perform all activities in compliance with SOP’s, cGMP and SHE
Maintain and further develop an in-depth understanding of all pertinent SOP’s, GLP, GCP, GMP and safe work practices.
Job Requirements
Education/Qualifications:
Bachelor of Science in chemistry or related field.
Minimum three 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.
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
To apply for this job please visit careers.apotex.com.