Quality Assurance Director
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.
- 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);
|Salary:||$70K to $95K + fringe benefits|