About this role: Quality Assurance Specialist ~ Product Management
We have a fulltime position available with our client who is a global biopharmaceutical company focused on human health. The opportunity is for a Quality Assurance Specialist, Product Management based in the GTA area.
The successful hire will be responsible for Product Quality related activities for the importation and distribution portfolio. Play a key role in establishing and maintaining high quality and compliance status of all products handled by the company to meet all Canadian cGMP regulations as well as corporate requirements.
- Serve in a backup capacity to Product Quality Lead 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.
- Coordinate with external manufacturing sites to ensure Canadian regulatory requirements are consistently met in a streamlined fashion.
- Collect, review, and approve all required documentation necessary for product release, including batch documentation review.
- Perform periodic (eg. Annual) compliance requirements such as executed batch record review, stability review etc.
- Release products and APIs on Canadian market after completing necessary document review.
- 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.
- Create and maintain local product specification. Method review is part of batch documentation review.
- Send products for testing, approve results and support laboratories, if required Issue and execute Change Requests, Deviations, Investigations and CAPAs.
- Support Med Info requests.
- Other QA duties, as assigned.
- Must hold a university degree; this must be a Canadian university degree or a degree recognized as equivalent by a Canadian university or Canadian accreditation body in a science related to the work being carried out.
- Persons applying for positions in QA must provide evidence of qualifications, as outlined in Good Manufacturing Practices (GMP) Guidelines - 2018 current, for review and assessment by the Head of Quality or designate, as a condition of any offers of employment.
- 3+ years of relevant experience in pharmaceutical industry (QA, QC, Production or equivalent).
- Extensive knowledge of Canadian GMPs.
- Excellent analytical and problem-solving abilities Team player.
- Ability to maintain good interpersonal relationships.
- Ability to set priorities.
- Good communication skills (verbal and written).
- SAP, MS Office, Adobe Suite.
English: Excellent knowledge (reading, writing and oral).
French: Written and spoken proficiency an asset.
- Travel: Occasional
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Any questions remaining?
Your consultant, Angelina Brathwaite is happy to clarify anything about this vacancy. When reaching out, use the pub number:
Brunel Canada - Toronto