Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world.
We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion.
Our fully integrated operation is comprised of four lines of business : Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API);
and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year.
We produce 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.
Responsible for ensuring supplier related investigations at the site level for Apotex OSD and OLD are conducted in a timely and efficient manner leading to root cause elucidation and correction.
Ensures established procedures are followed for all investigations and preventative actions are implemented. Acts as technical resource and reviews all investigation reports for completeness and accuracy.
Prioritize investigations according to business needs.
Oversees Apotex OSD and / or OLD failures (raw materials, packaging components) at a site level.
Review and approve vendor investigations for raw material and packaging component failures for Signet, Etobicoke, and / or Richmond Hill sites following existing procedures.
Recognize critical path for investigations leading to timely identification of root cause, corrective & preventative actions.
Conduct impact analysis of proposed corrective & preventative actions. Discuss findings with impacted departments (QA, RA, Validation, Production, etc).
Identify gaps of current quality systems and / or procedures impacted by implementation of proposed preventative actions.
Liaise with given departments to ensure system / procedures are revised.
Liaise with QA Audit and escalate issues to Supplier Status Review, where for cause audits may be required based on criticality of deviations or trending data.
Prepare and maintain list of open investigations for Apotex OSD and / or OLD. Develop deviation trending parameters for business units, as requested.
Subject Matter Expert on the raw material failures and / or component failures.
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.
All other duties as assigned.
Bachelors degree in science / engineering.
Experience in the pharmaceutical industry
Experience in project management
Fluency in project management & RCCA tools
Superior organizational, interpersonal, and communication skills
Ability to manage time effectively
Ability to work independently and manage multiple priorities in a fast-paced and changing environment
Good command of the English language, both written and verbal
Knowledge of GMP
Proficiency with Word, Excel, and SAP
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.