Quality Assurance Director

ref.22659NA

Our client, in the manufacturing sector, is looking for a Quality Assurance Department Manager. As a member of the company's management team, you will participate in leading, planning and implementing a managment system for quality assurance, regulatory affairs and quality control.

  • Establish procedures for the management and control of documents; production records, analysis management, corrective and preventive measures, change management and an internal audit program;
  • Review and approve all procedures, control forms, production documents, validation and stability protocols and reports related to product quality;
  • Release materials used for manufacturing and packaging and release for distribution products found to be compliant after examination of production records and laboratory analyzes;
  • Carry out internal audits and the annual product quality review;
  • Ensure that deviations, audit findings and complaints are investigated, that root causes are established and that action is taken;
  • Recruit and train staff;
  • Provide training on regulatory and standards requirements (BPF and ISO) to all company personnel;
  • Monitor legislation and regulations relating to GMP and standards relating to the quality system and advise Management with regard to the implementation.
Requirements:
  • DEC or Bachelor's in Chemistry or scientific training;
  • 5 years of experience in audit, regulatory affairs, quality assurance;
  • 2 years of experience in team management;
  • GMP knowledge for Canada, United States and Europe on active pharmaceuticals ingredients (API);
  • Computer skills (Microsoft Office, ERP);
  • Bilingual.
Location: South Shore
Salary: $70K to $95K + fringe benefits

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