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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.
The Corporate Quality & Compliance Project Leader is responsible for facilitating functions related to Critical Event Management/Escalation, Regulatory Notification and Product Recall, including liaising with local and international regulatory agencies, customers, vendors and affiliates. Data analysis, report writing and technical writing are major components of this role.
- Responsible for ensuring Escalations, Field Actions and Regulatory Communications are managed and completed in a timely manner as per applicable regulatory requirements and Apotex’s approved procedures.
- Liaises with Apotex Affiliates to provide appropriate notification of critical events and coordinate investigations, recall activities and procedures.
- Assist the Manager, Global Field & Market Response in meeting departmental goals and objectives.
- Completes Recall Submissions and Recall Status Reports.
- Ensures Recall and Escalation related documentation are issued; reports and files are completed and follow-up is conducted for corrective and preventive actions related to Recalls, Regulatory Notifications including Field Alert Reports.
- Participates in the preparation of Apotex Escalation Committee Meeting materials.
- Creates and drives to completion change controls as well as manages the review and approval process for centralized SOPs originated from Global Field & Market response department.
- Ensure that all centralized function SOPs (applicable to the Global Field & Market Response Department) are issued as per the required standards and are revised within the required timelines.
- Provides support during revision of Global Policy and Global Standard Operating Procedures applicable to the Global Field and Market Response team (as needed).
- Recommends and participates in the implementation of process improvement initiatives.
- Ensures that all work is performed in full compliance with Good Manufacturing Practices, Standard Operating Procedures, established safety standards, and regulatory requirements. Responsible and accountable for following and implementing safety regulations in accordance with the Occupational Health and Safety Act, Apotex’s Health and Safety Policies and Safe Work Procedures (SWPs).
- Compiles/summarizes monthly and quarterly trend reports as required. Creates monthly metrics for departmental work as related to Escalation, Recalls and Regulatory Notifications.
- 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.
- Sc. in Chemistry, Biochemistry or a related science (or an equivalent combination of post-secondary education and related work experience).
- Minimum five years of experience in a quality assurance (QA) or quality control (QC) role. Experience in the pharmaceutical, food or cosmetics industry is required for this role.
- Proficiency commensurate with job requirements in SAP, Word, Excel, Access and other Windows software packages.
- Knowledgeable regarding GMP requirements for drug products.
- Strong interpersonal, communication and facilitation skills.
- Excellent oral and written English communication skills.
- Ability to work independently with minimal supervision.
- Strong organizational and time management skills.
We have adapted our recruitment strategy to ensure our staff and applicants are safe by conducting our interviews and onboarding online.
Other measures Apotex has put into place include (but are not limited to):
- staggering employee shifts to reduce the size of work groups
- modifying our cafeteria space to enhance social distancing, the implementation of additional cleaning and sanitization routines
- robust self-assessment and screening tools
- non-surgical masks for employees working in GMP areas
- travel restrictions
- work-from-home policy for all employees who can perform their roles remotely
- strict visitor screening protocol
It is important to note that while these are our protocols at this time, they are subject to change based on guidelines and regulations put in place by local and global government agencies.
For up-to-date information about Apotex’s ongoing efforts in response to COVID-19, visit: https://www1.apotex.com/global/covid-19-update or follow us on LinkedIn and Twitter
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.
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