Process Validation Coordinator - Day shift

Who we are

Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

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

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

How you'll spend your day

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.
  

Your experience and 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
  

Already Working @TEVA?

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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. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.