Introduction

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.

What are you going to do

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.

Essential skills and knowledge 

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

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.

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