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.
This department is responsible and accountable for the administration of the Apotex Inc. Cleaning Validation Program, and ensuring compliance with the applicable regulatory bodies. This department is also responsible for driving a consistent approach to cleaning validation across the manufacturing sites. Responsible for assisting in the planning, execution and tracking of cleaning validation activities in accordance with FDA, HPFBI, EC, and ICH’s guidelines and applicable Apotex policies and processes.
Performs cleaning validation sampling of manufacturing equipment for product drug active, detergent and microbial residues.
Communicates analytical testing priority to the lab for all swab sampling.
Provides troubleshooting assistance for remedial and corrective actions in the case of unacceptable validation results.
May assist in the review and assessment, in conjunction with the Project Leader/Supervisor, of proposed changes to production equipment and cleaning procedures on the validation program using the appropriate change control procedures.
Extract and consolidate data from laboratory, production and packaging documents.
Help to organize, manage and update cleaning validation tracking database.
Participate in the monitoring program including viewing of the cleaning validation activities and completion of protocol checklists.
Performs other related duties as assigned.
Currently enrolled in post-secondary Science, Engineering or related discipline.
Command of Microsoft Excel, Word and Access required.
Well-developed interpersonal skills.
Good communication skills (written & verbal)
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.