ST-Coordinator, Equipment and Facility Qualification (8 months, Summer 2023, co-op student)
Date: Mar 16, 2023
Location: Etobicoke, ON, CA, M9W 6Y3
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
Responsible for qualification of production/plant equipment and facility systems meeting global regulatory guidelines. Identifies bottlenecks, makes recommendations, and suggests corrective actions, where possible. Assists in co-ordination of qualification projects, protocols and reports.
Job Responsibilities
- Author Installation, Operation, and Performance qualification protocols and reports to ensure that equipment is correctly installed and operates as per the design and user’s specifications and is in compliance with the cGMP requirements.
- Collaborate with other departments as required to achieve department objectives and business needs.
- Coordinate the Equipment and Facility Qualification and Environmental Mapping activities as required.
- Support projects and expansion efforts with respect to qualification of equipment, facilities, and utilities, and attend meetings as required.
- Participate in investigations, audits, and improvement initiatives related to equipment, facility, and utilities’
- qualification.
- Re-qualify controlled spaces, and re-evaluate the qualification status of designated equipment/facilities at the defined periodic intervals.
- Review departmental systems and procedures on a periodic basis for compliance and suggest improvements as required.
- Participate in monthly department meetings as required.
- 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.
- Assists EFQ Supervisors and Manager in meeting department’s goals and objectives.
- All other duties as assigned.
Job Requirements
- Must be enrolled in a recognized post-secondary co-op education program (Area of study: Engineering or related discipline.)
- Well developed interpersonal skills.
- Command of Microsoft Word, Excel, Access and Power point.
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.