Process Validation Coordinator

1 week ago


WhitchurchStouffville, Ontario, Canada Teva Pharmaceuticals Full time

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


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