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Process Validation Coordinator

Date: Sep 21, 2022

Location: Stouffville, Ontario, CA, L4A 1H5

Company: Teva Pharmaceuticals

Who are we?

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

Process Validation Coordinator - Day Shift
Stouffville, Ontario 
Full-time, permanent 


We are currently seeking a Process Validation Coordinator to join the team.  

 

Roles and responsibilities will include but are not limited to:

  • Write and develop computer based process validation protocols using templates for process validation studies which detail scope, IQ/OQ, process flow charts, critical process parameters, sampling plans, testing plans and acceptance criteria.
  • Maintain and modify validation templates to reflect on-going program changes and standard business practices.
  • Coordinate process validation study activities with all associated departments including Stouffville Planning and the Quality Control Laboratories ensuring that procedures conform to protocol requirements and standard business practices..
  • Prepare all process validation study sample supplies based on specific protocol requirements prior to the scheduled start of the validation study and communicate readiness with Technical Operations and Operations Personal.
  • Process all validation study samples including coordination and communication with Quality Control Laboratories and QPIC personal for sample transport and testing.
  • Evaluate all validation study lab LIM’s data including excursions (OOT / OOS) and LIR’s where applicable and notify supervisor
  • Evaluate all validation study executed batch documents for in-process data and any potential deviations (DR’s), protocol excursions or quality occurrences and notify supervisor.
  • Write computer based process validation reports including tabulated / graphed data and applicable statistics based on executed validation protocols, in-process results and laboratory results.
  • Perform peer review of validation reports prior to circulation for approval for data integrity purposes.
  • Maintenance of individual project folders within the departmental shared folder.

Qualifications

  • Bachelor’s degree in Science, Engineering or related discipline
  • Two (2) + years Process Validation experience
  • Computer literate and proficient in: Microsoft Word, Excel, PowerPoint, Adobe Reader, Outlook Applications, LIMS, and Knowledge Tree and Harmony Trackwise

Function

Manufacturing

Sub Function

Technical Transfer

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.