POSITION TITLE: Quality Validation Specialist POSITION TYPE: Permanent Regulatory Affairs Founded in 1916, Kohl & Frisch Limited has a solid reputation in the healthcare industry that distinguishes it as the only national, Canadian-owned and operated wholesale distributor. A family-owned company, it is one of Canada’s leading national distributors and is the essential link between pharmaceutical manufacturers and healthcare providers. Kohl & Frisch is fully equipped to service large chain retailers, independent pharmacies, clinics, and hospitals for all their Rx, OTC, home healthcare, and front shop needs The Quality Validation Specialist will be responsible for carrying out all the steps leading to the validation of warehouse equipment (i.e. freezers, fridges) and warehouse mapping associated with the warehousing of pharmaceutical products in a pharmaceutical wholesaler environment.

The Quality Validation

Specialist will work in the Regulatory Affairs department and shall ensure Operations is compliant to applicable GMP standards as defined by GUI-0001 "Good Manufacturing Practices" and GUI-0069 "Guidelines for Environmental Control of Drugs during Storage and Transportation". Execute or assist Operations personnel in the execution of validation protocols according to the validation schedule, which includes new equipment qualifications, re-qualifications,



and winter / summer warehouse mapping when applicable Provide technical support / train Operations personnel during validation for K&F;'s Distribution Centers across Canada Provide support to IT for any GMP-related software validation updates which include documenting qualifications (OQ, IQ, PQ) for our warehouse management software system Ensure the integrity and traceability of the information produced and reported, making necessary corrections in compliance with GMP and the company’s internal standards Perform document review, including revising and correcting internal documents (SOPs) relating to equipment qualification and mapping Participate/gather data for seasonal shipping studies in Concord. Work with Regulatory team on analysis and reports for seasonal shipping studies for other DCs Work closely with the Quality Control Specialist and Operations personnel and perform audit checks on GMP documentation in the warehouse (primary work site) Support Regulatory department as needed Bachelor of Science, Engineering or equivalent Minimum of 5 years of experience in a Pharmaceutical Healthcare Quality environment Experience with equipment validation/report writing in a pharmaceutical environment Knowledge of Positive Manufacturing Practices (GMP) Working knowledge of Microsoft Office and Excel Keen attention to detail and proven ability to analyze and interpret data Ability to travel to other Distribution Centers across Canada when required to help support validation (15 - 25%) #

📌 Quality Validation Specialist (Toronto)
🏢 Kohl u0026 Frisch
📍 Toronto