POSITION TITLE: Quality Validation SpecialistPOSITION TYPE: PermanentLOCATION: Kohl & Frisch Limited (Concord, ON)DEPARTMENT: Regulatory AffairsAbout UsFounded 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 needsAbout the RoleThe 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 "Positive Manufacturing Practices" and GUI-0069 "Guidelines for Environmental Control of Drugs during Storage and Transportation".What will you do?Develop validation protocols and reports to meet Health Canada's requirementsExecute 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 applicableIdentify opportunities for improvementProvide technical support / train Operations personnel during validation for K&F's Distribution Centers across CanadaProvide support to IT for any GMP-related software validation updates which include documenting qualifications (OQ, IQ, PQ) for our warehouse management software systemEnsure the integrity and traceability of the information produced and reported, making necessary corrections in compliance with GMP and the company's internal standardsPerform document review, including revising and correcting internal documents (SOPs) relating to equipment qualification and mappingParticipate in Health Canada's Audits if requiredOther functions may include:Participate/gather data for seasonal shipping studies in Concord. Work with Regulatory team on analysis and reports for seasonal shipping studies for other DCsWork 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 neededWhat you bringBachelor of Science, Engineering or equivalentMinimum of 5 years of experience in a Pharmaceutical Healthcare Quality environmentExperience with equipment validation/report writing in a pharmaceutical environmentKnowledge of Good Manufacturing Practices (GMP)Knowledge of GMP Regulations and validation requirements for Health CanadaWorking knowledge of Microsoft Office and ExcelKeen attention to detail and proven ability to analyze and interpret dataExcellent oral and written communication skillsAble to work onsite in a warehouse environmentAbility to travel to other Distribution Centers across Canada when required to help support validation (15 - 25%)