Quality Validation Specialist

POSITION TITLE: Quality Validation Specialist POSITION TYPE: Permanent LOCATION: Kohl & Frisch Limited (Concord, ON) DEPARTMENT: Regulatory Affairs

About Us

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%)

How to Apply

If you are interested in applying, please submit a résumé and any other relevant documentation to: [email protected].

Please ensure you specify the job title, Quality Validation Specialist in the subject line of your email.

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.