Quality Validation Specialist

Kohl & Frisch Limited; Vaughan; On-site; CAD 95,000 - 120,000; Full time

Benefits offered by this job

Bonus or incentive program

Pension plan

Health, dental, vision

Vacation pay

Wellness programs

Employee assistance program

Professional development

Job summary

Kohl & Frisch Limited, a leading Canadian pharmaceutical distributor, is seeking a Quality Validation Specialist for its Regulatory Affairs team. The role focuses on validating warehouse equipment and mapping under GMP guidelines, with responsibilities spanning protocol development, execution, and IT collaboration for software validation.

The candidate should have a Bachelor of Science or engineering, 5+ years in a pharmaceutical quality environment, and be willing to travel 15–25% across

Qualifications

• Bachelor of Science, Engineering or equivalent.
• Minimum 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.
• Proficient in Microsoft Office and Excel.

Responsibilities

• Develop validation protocols and reports to meet Health Canada’s requirements.
• Execute or assist Operations personnel in validation according to the validation schedule (new equipment qualifications, re-qualifications, warehouse mapping).
• Identify opportunities for improvement.
• Provide technical support and train Operations personnel across Canada.
• Support IT for GMP-related software validation updates (OQ, IQ, PQ).
• Ensure integrity and traceability of information produced and reported per GMP standards.

Skills

GMP knowledge

Excel

Attention to detail

Communication skills

Onsite work

Travel willingness

Equipment validation

Documentation

Education

Bachelor of Science or engineering

Tools

MS Office

Warehouse management software

Job description

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.

About the Role

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”.

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)
• Health, dental, vision from day 1
• Personal Days
• Employee Assistance Program
• Opportunity for Professional Development
• Wellness programs
• Vacation Pay
• Exclusive memberships and discounts

As part of our recruitment process we may use AI for initial screening and assisting in evaluating candidate qualifications. All final hiring decisions will be made by our recruitment team.

Kohl & Frisch would like to thank all applicants for their interest. All applicants who received interviews will receive an update on their application status within 45 days of last interview. We value your interest in joining our team and strive to provide a timely, transparent hiring experience.

Kohl & Frisch Limited welcomes applications from individuals with disabilities and provides accommodations upon request for candidates taking part in the selection process.