Quality Validation Specialist

About 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 needs.
About 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 “Good 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 requirements
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
Identify opportunities for improvement
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 in Health Canada Audits if required
Other 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 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
What You Bring
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 Good Manufacturing Practices (GMP)
Knowledge of GMP Regulations and validation requirements for Health Canada
Working knowledge of Microsoft Office and Excel
Keen attention to detail and proven ability to analyze and interpret data
Excellent oral and written communication skills
Able to work onsite in a warehouse environment
Ability to travel to other Distribution Centers across Canada when required to help support validation (15 – 25%)
What’s in it for you?This position offers a salary range of $95,000 - $120,000, exclusive of discretionary bonus eligibility and our full benefits package. The final salary offered to the selected candidate will be determined by factors including location, relevant experience, skill level and education.
Additional Compensation (if applicable):
Bonus or commission structure
Pension Plan (eligibility after 18 months service)
Benefits:
Health, dental, vision from day 1
Personal Days
Employee Assistance Program
Opportunity for Professional Development
Wellness programs
Vacation Pay
Exclusive memberships and discounts
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