Quality Manager

North York - Ontario - Canada - Life Sciences & Health Care - Pharmaceutical - Regulatory - Academic Bachelor

This company is the largest company in the world devoted entirely to vaccines. This dedication to research and innovation employs around 15,000 employees worldwide, supporting the production of over 1B doses of vaccines annually. The company offers great benefits and room for growth and advancement, as they are known to invest in research and development.

Feel free to contact

Diana Grodowski, Account manager

Apply now

About this role

Responsibilities

  • Define and manage the processes for quality control of suppliers and service providers e.g. managing supplier change notifications, supplier deviations, specifications, quality agreements, etc.
  • Ensure Quality Technical Agreements (QTAs) are in place, as required
  • Liaise with the vendor auditors, when required for QTAs and participate in vendor audits, as required
  • Manage supplier deviations related to suppliers and GxP service providers
  • Manage Change Controls related to supplier changes notifications
  • Participate on Project Teams as required
  • Lead assessment of Supplier Change Notifications and CCRs within required timeframes and ensure required deliverables are completed 30%
  • Maintain the Quality Third Party Database (Phenix) for materials and services used by SPL 10%
  • Manage supplier deviations to ensure timeliness and compliant investigation 20%
  • Lead creation, review and approval of specifications for Supplier Quality 20%
  • Support creation, review and approval of procedures for Supplier Quality 10%
  • Support audit of suppliers and service providers to ensure that the manufacturing of raw materials, consumables, manufacturing aids and packaging components meets GMP/ISO requirements. 5%
  • Perform, monitor, and communicate Key Performance Indicators (KPis) to suppliers and service providers 5%

About you

Requirements

  • 5 years of industrial experience in the Pharmaceutical/Biotech Sterile Manufacturing or Quality environment.
  • Experience in various GMP pharmaceutical/biological manufacturing such as testing, facilities, validation and utilities. May consider ISO experience as well, but GMP is preferred.
  • Experience with electronic database, document and information management (e.g. Documentum, SAP, Excel (basic), TrackWise, etc.) - if no previous knowledge, they may be trained on this but would be highly desirable.
  • Proficiency in computer software applications, i.e.: Microsoft Office
  • Document, information and data organization skills
  • Minimum Bachelor of Science Degree, specializing in either Chemistry, Biochemistry

What we offer

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.

About us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

Summary

  • Vacancy number: PUB217485
  • Location: North York
  • Market: Life Sciences & Health Care
  • hours per week: 35
  • Branche: Pharmaceutical
  • Education level: Academic Bachelor
  • Area of Expertise: Regulatory
  • Closing date: Friday, August 2, 2019
Apply now

Feel free to contact

DG

Diana Grodowski

Account manager Brunel Canada Toronto

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