Quality Specialist in Montréal, Communauté-Urbaine-de-Montréal, Québec, Canada

Were hiring Quality Specialist for our client, a publicly traded Canadian pharmaceutical company that works within injectable prescription medicine, to join their Quality team. This is a permanent position with a growing team.



About this role

Responsibilities

  • Create specifications and acceptability criteria
  • Ensure that manufacturing, packaging and analysis of products are defined, controlled and in accordance with Good Manufacturing Practices (GMP)
  • Revise stability data and approve the new test or expiration date
  • Qualify service providers: inspect their facilities; identify and recommend corrective and preventive actions
  • Negotiate quality agreements with various external partners
  • Evaluate finished product quality and decide whether to retain the batches or release them for distribution
  • Ensure all GMP steps are followed and in compliance
  • Participate in the evaluation of complaints to determine causes and recommend corrective and preventive actions
  • Evaluate incidents and provide preventive and corrective actions
  • Facilitate the conduct of audits and carry out internal and external audits
  • Contribute to the preparation of budgets for quality activities and monitor them
  • Maintain the policies and procedures of the pharmaceutical compliance program to avoid conduct that may lead to ethical misconduct
  • Collaborate with different departments if a compliance issue is raised to determine what actions to take to resolve the issues
  • Analyze complaints or queries related to violations of rules, policies, procedures and codes of conduct and propose the required solutions
  • Facilitate the circulation of compliance information to all stakeholders of the Company
  • Ensure policies and procedures are written and reviewed to ensure compliance with standards
  • Revise any document, packaging and label to ensure compliance
  • Contact person for quality assurance
  • Act as a representative of quality and compliance service on various committees and work teams
  • Evaluate and ensure the disposition of the returned product
  • Revise and approve documents, specifications, procedures, labels, packaging products, manufacturing and packaging master files, protocols, validation reports, deviations
  • Check the temperature data during the transportation of the products and decide on their status / arrangement
  • Determine the disposition of the non-compliant product and propose the required solutions
  • Establish and maintain a change control system
  • Review production documentation and investigations for customer complaints related to product manufacture and packaging
  • Analyze statistical data on complaints and deviations, recommend actions
  • Write procedures, specifications, explanations, preventive and corrective actions, change requests
  • Revise and approve the annual product quality review
  • Produce forms, memos, lists and reports to document everything that needs to be


About you

Requirements

  • Bachelor's degree in pharmacy, chemistry, biology or chemical engineering
  • Training in quality assurance
  • 3-5 years experience in quality assurance in the pharmaceutical industry, ideally with sterile products, pharmaceuticals and / or biological
  • Experience in Oncology is desirable or other therapeutic areas
  • A good understanding or experience in laboratory research, preclinical and / or clinical research is an asset
  • Experience in conducting or contributing to audits
  • Experience with policies and procedures of the Pharmaceutical Compliance Program
  • Know the terminology of quality assurance
  • Good knowledge of GMP, GLP, BPD and guidelines and regulations of the pharmaceutical industry
  • Knowledge of Word, Excel, Power Point and Outlook
  • Have worked with databases
  • Bilingual French-English, spoken and written


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. Thats what we continually strive for. Over 40 years, weve created a global network of interesting clients and talented individuals working together through a vast array of services.

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