Quality Validation Specialist

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

Benefits offered by this job

Health, dental, vision

Pension Plan

Vacation Pay

Employee Assistance Program

Professional Development

Wellness programs

Exclusive memberships and discounts

Job summary

Kohl & Frisch Ltd in Vaughan, Canada, seeks a Quality Validation Specialist to lead validation of warehouse equipment and mapping for pharmaceutical storage in a GMP environment.

You will develop protocols, perform validations (IQ/OQ/PQ), train Operations staff, support GMP software validation, and participate in Health Canada audits, with travel to other Distribution Centers 15–25%.

Qualifications

• Five years of experience in a pharmaceutical healthcare quality environment.
• Experience with equipment validation/report writing in a pharmaceutical setting.
• Knowledge of GMP and Health Canada validation requirements.

Responsibilities

• Develop validation protocols and reports to meet Health Canada requirements.
• Execute or assist with validation of new equipment and re-qualifications per schedule.
• Provide training to Operations staff during validation for Distribution Centers across Canada.

Skills

Attention to detail

Communication skills

Travel availability

Education

Bachelor of Science

Tools

Microsoft Office

Excel

Job description

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%)

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