Job Description

Job Title: Canada-Quality Assurance Associate II (Scientific)
Duration: 06+ months with possible extension
Location: Mississauga, ON

Summary:
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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