ST-Associate, Corporate Quality Audit (8 Month Co-Op)

Date: Jan 12, 2021

Location: North York, ON, CA, M9L 1T9

Company: Apotex


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

Working in a highly regulated pharmaceutical GMP environment, responsible for generating, analyzing and interpreting data pertinent to Apotex Corporate Quality audit space for better Predictive Analytics. Also responsible for working with electronic Enterprise systems such as Quality Management System TrackWise (QMS TW), Systems Applications and Products (SAP) and Laboratory Information Management System (LIMS) to extract and report GMP data for the purpose of Supplier Risk Profiling, Supplier Scorecard, Excipient Risk Assessment and supplier qualification process. This job also requires liaising with third party suppliers and Apotex network sites for communicating pertinent information impacting Corporate Quality Audit space and requesting information to make informed decisions.

Job Responsibilities

• Migrate following third-party suppliers from Apotex Quality Reporting System (AQRS) Trackwise into the current QMS TW system for amalgamation:
     Sterile Consumables
     Primary Packaging Suppliers
     Secondary Packaging Suppliers
     Pharmaceutical Excipient Suppliers
     Warehouse / Transportation Service Providers / Distribution Services
     Contract Manufacturer Organization (CMO) - Natural Health Products and Food Supplements
     Contract Manufacturer Organization (CMO) - Medical Device
• Create Third Party Site Header (TPSH) for the new Apotex and Pharmachem suppliers
• Reconcile new audit requests with existing TPSH to evaluate the need to create new TPSH
• Reconcile master data in SAP against master data in QMS TW pertinent to all suppliers
• Generate lists of requests to obtain information from suppliers for desktop/remote audits
• Provide support in SOP revision and updates
• Manage and reconcile the ‘Partner’ folder
• Gather data for audit trending for Predictive Analytics
• Prepare monthly metrics report
• Provide audit information to different Apotex sites as required
• Generate audit history/reports required to support regulatory and customer inspections
• Perform all work in accordance with all established regulatory, compliance and safety standards
• Demonstrate Behaviours 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
• Other job functions as required

Job Requirements

• Enrolled in a Post-secondary Co-op education program (Science or Regulatory affairs related program)
• Background in pharmaceutical/chemical or related field would be an asset
• Excellent verbal and written communication skills
• Advanced computer skills, including Microsoft Office Products and SAP or another ERP
• Good understanding with electronic data repository systems
• Demonstrated organizational skills and strong attention to detail
• Demonstrated ability to effectively manage multiple priorities in a fast-paced environment
• Demonstrated ability to exercise discretion, maturity, good judgement and maintain strict
 confidentiality when exposed to, and handling, sensitive and confidential information



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.