Project Leader, Production Investigations

Project Leader, Production Investigations

01 Aug
|
Apotex Inc..
|
Etobicoke

01 Aug

Apotex Inc..

Etobicoke

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 ensuring root cause analysis is conducted on investigations for Apotex OSD in a timely and efficient manner. Ensures established procedures are followed for all investigations and corrective and preventative actions are implemented. Acts as quality technical resource and reviews all investigation reports for completeness and acccuracy, and compliance.



Job Responsibilities



- Conducts all Apotex OSD failures or deviations (product, validation, stability, process and procedures) and ensures investigations are initiated following existing procedure.

- Conducts investigations for product failures or deviations for both Signet and Etobicoke sites following existing procedures. Recognize critical path for investigations leading to timely identification of root cause, corrective & preventative actions. Writes product failure investigation reports for approval by Department Manager.

- Notify appropriate Team Leaders of validation, raw material, stability & in-process failures and ensure investigations are initiated and completed as per existing procedure. Act as quality technical resource and provide support & guidance to groups within Operations.

- Ensure identification of most probable root cause, corrective action & preventative action for all completed investigations. Review all investigation reports for completeness and accuracy prior to approval by Department Manager.

- Conduct impact analysis of proposed corrective & preventative actions. Discuss findings with impacted departments (QA, RA, Validation, Production, ect) and prepare recommendations for Department Managers.

- Prepare and maintain list of open investigation for Apotex OSD Management.

- Review on-going progress on all open investigations with Project Leaders and Coordinators.

- Ensure investigations are issued; tasks are appropriately assigned for completion or corrective and preventative actions and are closed in a timely fashion.

- Project manages the corrective and preventative actions and assists in both implementation and follow-up.



Job Requirements



- Bachelors degree in science

- 5-7 years experience in the pharmaceutical industry, preferably in Quality Engineering or QA/QC role.

- Experience in project management

- Fluency in project management & RCCA tools

- Superior organizational, interpersonal 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.



Covid 19 Update



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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