Quality Assurance Manager

PUB317148

About this role

About this role

We are currently hiring a Quality Assurance Manager for our client who is a specialty pharmaceutical company focused on innovative prescription pharmaceuticals globally. This is a permanent full-time opportunity based out of Montreal, Quebec. Reporting to the Quality Associate Director Canada and Latam, the QA Manager will assume responsibilities to ensure the compliance of pharmaceutical products in Canada as well as to maintain quality compliance with Good Manufacturing Practices (GMP) and the company Standard Operating Procedures (SOPs).

Responsibilities

  • Represent the company as the Quality Person in Charge (QPIC) for Health Canada.
  • Expand internal processes for the development of the people from Quality Assurance department.
  • Generate of annual product quality review.
  • Review Quality Agreements.
  • Manage of Deviations and CAPAs.
  • Coordinate the timely collection of GMP evidence with corporate partners for product specific updates of Drug Establishment License.
  • Maintain Site licenses and prepare related amendments and notification to Health Canada.
  • Manage the lot release of pharmaceutical and natural health products to the Canadian market.
  • Manage the changes made to marketed products.
  • Handle marketed product complaints, in collaboration with corporate partners.
  • Participate in on-site Health Canada GMP audits and, as required, conducting inspections of suppliers involved in the manufacturing and/or distribution of pharmaceutical and natural health products.
  • Act as the qualified person for quality compliance matters raised internally, by suppliers or corporate partners.
  • Coordinate any required product recall procedure as per internal SOPs.
  • Participate in the preparation of CTD modules or responses related to the Chemistry and Manufacturing component of a regulatory dossier.
  • Evaluate processes, results, operations, and trends to ensure compliance with local and international standards related to GMP, GLP, GDP. GSP, GPP.
  • Review quality KPIs and reports.
  • Support the implementation of the Quality Management System (software QMS).

Requirements

Requirements

  • B.Sc, M.Sc or PhD in Science
  • Minimum of 6 years within the pharmaceutical industry, including Quality Assurance
  • Strong scientific knowledge.
  • Excellent communication skills; written and oral English; Spanish is desirable.
  • Strong knowledge of Microsoft Office Suite.
  • Experience in People Management is desirable.

Benefits

Benefits

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Join the Brunel Family

Join the Brunel Family

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Start applying immediately

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Any questions remaining?

Your consultant, Chris Kapusta is happy to clarify anything about this vacancy. When reaching out, use the pub number:
PUB317148

Account manager

Chris Kapusta
Brunel Canada - Calgary
c.kapusta@brunel.net

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