Canada-Quality Assurance Associate Ii (Scientific) #: 23-09980

Job Title: Quality Assurance Associate II (Scientific)
Location: Mississauga, ON L4W 4V9
Duration: 6+ months
Contribute to establishing and maintaining high quality and compliance status of all products handled by *** to meet all Canadian cGMP regulations as well as Corporate requirements.
Key Responsibilities And Duties For This Job

• Collect, review and approve all required documentation necessary for product release, including batch documentation review
• Plan and coordinate product release activities.
• Send products for testing, approve results and support laboratories, if required
• Release products and APIs on Canadian market
• Coordinate and maintain specifications and methods
• Serve in a backup capacity to QA Manager and other QA Specialists for their respective responsibilities.
• Issue and perform work related to Change control Requests, Deviations, Investigations and CAPAs
• Other QA duties, as assigned
• Collect, review and approve all required documentation necessary for stability study program and APQR
• Support MedInfo requests
• Review documentation and release Clinical Supply Materials, products under the programs Special Access to Drugs and Health Products and Access to Drugs in Exceptional Circumstances
• Provide QA expertise to internal and external partners

Key Requirements For This Job
EDUCATION

• B.Sc. in Chemistry, Biology or related sciences *

Experience

• Extensive knowledge of Canadian GMPs especially for importer and distributor
• 3 years of relevant experience in pharmaceutical industry (QA, QC, Production or equivalent)

Specific Skills

• Ability to maintain good interpersonal relationships
• Good communication skills (verbal and written)
• Team player
• Ability to set priorities
• Excellent analytical and problem-solving abilities

Languages

• French as an asset
• English written and spoken

Job #: 23-09980