Quality Assurance Specialist ~ Product Management

Introduction

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.

Responsibilities

• 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.

Requirements

• 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.
• Languages:

English: Excellent knowledge (reading, writing and oral).

French: Written and spoken proficiency an asset.

• Travel: Occasional

What We Offer

Why apply through Brunel? Finding the next step in your career can be a fulltime job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with on-boarding. We’ll get you going while you get on with the job.