Quality Validation Specialist

Kohl & Frisch Limited; Toronto; On-site; CAD 70,000 - 100,000; Full time

Job summary

Kohl & Frisch Limited is seeking a Quality Validation Specialist in Concord, ON to validate warehouse equipment and mapping for pharmaceutical storage. You will ensure GMP compliance and support regulatory activities across Canada.

The role requires a Bachelor’s degree in science or engineering, 5+ years in a pharma quality environment, and experience with equipment validation and Health Canada regulations. Onsite work at Concord facilities is expected.

Qualifications

• Bachelor’s degree in science/engineering or equivalent required.
• Minimum 5 years in a pharmaceutical/healthcare quality environment.
• Experience with equipment validation and GMP regulations.

Responsibilities

• Develop validation protocols and reports to meet Health Canada requirements.
• Execute validation activities for new equipment and re-qualifications per schedule.
• Provide training and support to operations during validation activities.
• Review documents (SOPs) related to equipment qualification and mapping.
• Support GMP software validation updates and maintain data integrity.

Skills

GMP knowledge

Data analysis

Communication skills

Attention to detail

Onsite warehouse work

Education

Bachelor of Science, Engineering or equivalent

Tools

Microsoft Office

Excel

Job description

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's 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%)