Quality Assurance Consultant Jobs

💊Do you love to advise clients about Quality, GMP and Regulatory activities?

💊Do you have experience with drug products, NHPs and medical devices?

💊Do you live in the Greater Toronto area and want to work for one of Canada's leading 3PLs?

If yes, talk to me about joining one of Canada's top-rated 3rd party solutions providers with an inclusive, culture working alongside a well-managed team as we have an opening for a permanent, full-time QA Consultant who is motivated to grow with the company?

About the company:

The company has been providing top notch distribution and warehousing solutions to leading pharma companies for over 25 years. I have worked with this company and I can tell you they are one of the best at what they do!

They believe in:

• Showing their appreciation of their teams’ efforts and hard work
• Promoting a “passion for being awesome in everything we do" mentality
• Taking care of their own and creating a welcoming, inclusive, culture of helping others succeed
• Innovation being achieved by working with people with diverse perspectives.

The Perks:

• Family-like environment with a great culture that celebrates their wins and the team’s efforts
• Company sponsored events like Day at Wonderland etc.
• Depending on experience, 60 to 100K with fully comprehensive benefits package (Medical/Dental/Vision/LTD/STD benefits start on Day 1, Floater and personal days)
• Report to a great manager with lots of hands-on training and development
• Hybrid work environment
• Room for growth

Role Summary:

The QA Consultant is responsible for QA and regulatory activities related to the importation and distribution of client drug and natural health products as well as active pharmaceutical ingredients and medical devices. The QA Consultant is also responsible for QA and regulatory activities when acting as Canadian QA for a client. Develop and promote procedures and initiatives to ensure compliance to Health Canada regulations and GMP.

What you bring to the table:

• Excellent communication skills
• Excellent analytical skills and above average attention to detail
• Client-facing experience to advise, guide and build strong relationships
• Bachelor of Science
• Previous management experience with product importation/distribution is an asset
• Intermediate level knowledge of MS Word, Excel and Outlook
• Excellent time management and prioritization skills
• Knowledge of GMP & regulations as it relates to the importation and distribution of pharmaceutical products & medical devices
• 4 years experience in QA in a pharmaceutical environment with a minimum of 3 years of regulatory experience especially with licensing activities

What will you be doing?

• Ensure proper storage and transportation of products, taking action in case of temperature excursions
• Perform or coordinate vendor/contractor audits
• Report product complaints and adverse events to the client and QA Management, notifying Health Canada as required
• Conduct self-inspections, participate in external audits, and address observations
• Review and release product lots or batches - Communicate any documentation issues that may affect product release or necessitate a recall to the client
• Establish Quality Agreements with the client and all parties involved in the product supply chain
• Develop and implement procedures to meet regulations regarding regulatory licenses and importation/distribution activities
• Obtain and review necessary documents to ensure compliance with Health Canada regulations for importing and distributing drugs, natural health products, active pharmaceutical ingredients, and medical devices
• Monitor product stability program and escalate issues to QA Management and the client
• Assist in generating annual reports and provide training to QA Associates and other employees
• Respond to client inquiries and attend meetings as necessary
• Identify the need for product recalls, assist in recall, complete necessary documentation, file with Health Canada and approve destruction of GMP documents
• Ensure compliance with company and client procedures
• Ensure the use of a qualified Canadian laboratory for product testing and successful method transfer
• File changes with Health Canada to maintain accuracy of regulatory licenses
• Maintenance of all regulatory licenses for the company and clients: (Establishment License, Site License, and Medical Device Establishment License) per Health Canada regulations
• Respond to quality incidents, initiate deviations, and lead investigations
• Participate in projects requiring QA input
• Obtain and review GMP evidence for foreign sites and action any regulatory concerns
• Review and approve Change Controls impacting importation, distribution, and Canadian QA activities