Job Description

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

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

KEY REQUIREMENTS FOR THIS JOB

EDUCATION

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

EXPERIENCE

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

SPECIFIC SKILLS

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

LANGUAGES:

• English written and spoken
• French as an asset

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