Quality Assurance Specialist

Location: Toronto M5V 3L9, Ontario Less CMAs, Canada 

Contract type: Permanent 

Job ID: 2768

Quality Assurance Specialist, North America  

The Quality Assurance Specialist role supports QA personnel to ensure LEO Pharma products are manufactured and distributed according to Canadian Food and Drugs regulations.  This function assists in maintaining quality compliance with Good Manufacturing Practices (GMP) and LEO Pharma Standard Operating Procedures (SOPs).

Your role:

•    Manage QA complaint handling process
•    Electronically file source PQC intake information from PSP or IQVIA (Medical Information)

•   Perform Complainant follow up to procure missing information and coordinate sample retrieval

•   Prepare Defective samples for shipment to Investigational site

•    Training Matrix management & support for Canada
•    Assist/ maintain a current list of all QMS activities that includes Deviation, CAPAs etc.
•    Assist QA in processing product returns, OSDs, Inventory Discrepancies
•    Support QA in batch releases:

• Procure (e.g. CoA, CoC) and electronically file batch release documentation in QA SharePoint

•  Perform Temperature assessments

• Document batch releases in Release Log

•    Support HA Inspections and Internal Audits
•    Assist QA with APQR and stability review preparation 
•    Assist QA with SOP revisions
 

Your qualifications:       

 •    University Degree in Scientific Discipline (Preferably Canadian) 
•    2-5 years pharmaceutical industry experience that includes regulatory and quality technical roles
•    Practical knowledge in Health Canada regulations (e.g. GUI-0001) and Quality Systems.
•    Excellent written and verbal communication skills 
•    High attention to detail
•    Excellent time management skills
•    Course work in Regulatory and/or Quality Assurance
•    Solid computer skills, using MS Office, & Veeva Vault
•    Bilingual (English/French) preferred
 

Beyond the skin

Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact.  Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet.

At LEO Pharma, we believe in the power of individuals to drive change. Our flat organizational structure empowers you to make a visible impact and offers versatile roles for professional growth. We value diversity and welcome applications from all qualified candidates, recognizing that our different perspectives, backgrounds, and attitudes enable us to make the best decisions. Join our passionate team at LEO Pharma and be yourself as we work together to make a difference.

For certain positions, LEO Pharma might complete a background check conducted by a third party.

Join us on our journey Beyond the Skin. Apply today!

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