Canada-Quality Assurance Associate II (Scientific)

仕事内容

50/50 remote onsite

POSITION 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 daily, weekly and monthly release activities.
• Coordinate the Change Control Program of manufacturing sites
• Evaluate and approve investigations
• Provide QA expertise to internal and external partners
• Collect, review and approve all required documentation necessary for product release, including batch documentation review
• Inspect and release products and APIs on Canadian market
• Inspect products, 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 Change Requests, Deviations, Investigations and CAPAs
• Act as QPIC backup and perform all related activities
• 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

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:
French and English written and spoken