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Cleaning Validation Associate

Date: Apr 20, 2021

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

 

The cleaning Validation Associate is responsible for planning and executing cleaning validation activities in accordance with FDA, HPFBI, EMA, and ICH’s guidelines and applicable Apotex policies and processes.

Job Responsibilities

 

  • Liaises with key business members to generate CV Product and Equipment Risk Assessment reports, when evaluating new and/or changes to product formulations and manufacturing equipment.
  • Generates Cleaning Validation protocols/studies, and subsequent reports.
  • Co-ordinates the cleaning validation event activities (sampling, cleaning, testing requests) and execute them.
  • Reviews lab results for compliance to validation protocol acceptance criteria, updates the appropriate tracking and filing systems, communicates results for equipment release, and summarizes data for validation reports.
  • As necessary, evaluates, maintains and orders sampling supplies.
  • Recommends changes to equipment cleaning procedures and sampling methods to allow for successful completion of cleaning validation studies.
  • Initiates and recommends changes to SODs, and master documents pertaining to cleaning validation. 
  • Performs impact assessment, in conjunction with the management team, for proposed changes to production equipment and cleaning procedures on the validation program using the appropriate change control procedures.
  • Provides technical assistance, in conjunction with the management team, related to validation to outside suppliers and various departments and divisions within Apotex.  May sit on necessary project teams as required.
  • Communicates project status updates to management through the use of tracking sheets (Excel or MS Project).

Job Requirements

 

  • Bachelor’s degree in Science or Engineering.  Degree in Chemical Engineering, Biology or Chemistry is preferable.
  • Minimum of 2 years’ experience in the pharmaceutical, food, cosmetics or other regulated industries.
  • Proven organizational, risk management, problem solving, and project and time management skills demonstrated by previous work experience, in order to manage multiple priorities in a fast paced environment
  • Excellent English oral and written communication

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.