Job Description

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: .

Job Summary

• Responsible for developing supplier relationships, managing supplier qualification, providing quality oversight of third-party suppliers and for supporting reduced testing program at Apotex network sites. The responsibilities include facilitating technical discussions between Apotex network sites and third-party suppliers, reviewing all investigation reports for scientific rigor, thoroughness, and accuracy ensuring timelines for compliance and business considerations are met.

Job Responsibilities

• Develop and maintain effective relationships with internal stakeholders such as Corporate Quality Audit, GAPI, GSTO, Site Quality, EMQ, NPL and external suppliers
• Establish excellence in partnership with third party suppliers to influence and find technical solutions for material related quality issues
• Facilitate technical discussions between Apotex network sites and third-party suppliers pertinent to material quality related investigations to align on confirmed root causes
• Proactively liaise with third party suppliers to evaluate the identified root causes at the supplier\'s end for material failures are scientifically robust and defendable
• Provide support and facilitate discussions between Apotex network sites and third-party suppliers to ensure a holistic impact assessment is conducted as a result of material quality failures
• Review and approve vendor investigations for raw material and packaging component failures at Apotex network sites following relevant corporate and site procedures
• Review and evaluate the proposed CAPAs by the third-party suppliers to ensure that these CAPAs are meaningful and will eventually prevent recurrence of failures of the same quality attributes of the materials
• Leveraging the Corporate Quality Audit program of the third-party suppliers, evaluate the full implementation of committed CAPAs and the effectiveness of the implemented CAPAs at the third-party supplier sites
• In the event when the investigations conclude that the material quality attributes failure at the Apotex network sites are due to issues related to laboratory testing, ensure that the Apotex network sites implement enhancements to the appropriate procedures and lab control system to prevent recurrence
• Identify the leading indicators/adverse trends of quality attributes and proactively develop a robust and holistic plan to mitigate the potential future material failures by liaising with the suppliers
• Evaluate the Apotex network sites\' and suppliers\' analytical methodologies for equivalency and to identify significant gaps that could lead to nonconformances and non-comparable analytical results
• Support in optimizing existing business processes and procedures of Supplier Quality function to achieve sustainable compliance
• Support Global Supplier Quality management on compiling and preparing pertinent information for escalation and Supplier Status Review meeting
• Establish and maintain an effective tracking and tracing mechanism for the purpose of monitoring the progress of open investigations and to ensure timely closure
• Trend types and compliant closure of investigations for the purpose of reporting monthly metrics
• Function as a lead investigator for the purpose of completing Apotex network sites\' failure investigations with the support of third party suppliers for raw material and packaging components
• Compile Quality Agreements for APIs, Excipients and Packaging Components suppliers
• Perform API stability data review and trending as required
• Works in a safe manner collaborating as a team member to achieve all outcomes
• 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
• All other relevant duties as assigned.

Job Requirements

• Education

• University degree in science (or an equivalent combination of post-secondary education and related work experience)
• Knowledge, Skills and Abilities

• Thorough working knowledge of cGMP requirements, interpretation and application in the pharmaceutical manufacturing environment.
• Detail-oriented, accurate and reliable.
• Ability to manage multiple priorities in a fast-paced environment.
• Possesses superior communication, organization and interpersonal skills
• Possesses superior organizational, critical thinking and problem-solving skills.
• Ability to work independently and/or as part of a team.
• Ability to build effective working relationships with internal and external stakeholders
• Working knowledge with major software platforms
• Working knowledge with Enterprise software platforms such as SAP, LIMS and TrackWise is an asset.
• Experience

• 5 years experience in the pharmaceutical industry
• Experience in project management

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.

Apotex