Quality Assurance Specialist ~ Product Management

PUB365840

About this job

  • Industry: Pharmaceutical
  • Area of expertise: Safety
  • Location: Etobicoke

What is required?

  • Hours per week: 40
  • Education level: Academic Bachelor

About this role: 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

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

Benefits

What We Offer

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  • Motivation Letter (optional)
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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:
PUB365840

Account manager

Angelina Brathwaite
Brunel Canada - Toronto
a.brathwaite@brunel.net

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