Quality Assurance Manager
Salary :
Activity area : Pharmaceutical and medical
Post category : Technologies
Province : Quebec
Region : Montreal and surroundings
Recruiter : Marc Dufresne
Contact us : mdufresne@st-amour.com
Job description :
Our client is a well-established global pharmaceutical company with a strong presence in Canada. It invests heavily in research and development, focuses on innovation in key therapeutic areas, and always puts patients first. Our client is actively seeking a proactive and competent Quality Assurance Manager to lead and support our quality initiatives in the field of research and development.
Main responsibilities:
- Quality System – Stay informed of any implementation or changes to international or national regulations and/or guidelines related to activities within the framework of GxP in R&D, and propose appropriate actions.
- Training – Provide advice and assistance to R&D staff in implementing their training processes.
- Quality Risk Prevention – Contribute to the definition, monitoring, and maintenance of quality risk prevention for projects under your responsibility, in collaboration with other R&D QA divisions and relevant departments.
Skills and qualifications :
- Scientific experience (e.g., pharmacist, master's degree in science).
- Solid knowledge of Good Clinical Practices (GCP) and other guidelines related to clinical development activities.
- Very good knowledge of regulatory requirements applicable in the United States (FDA) and Canada.
- Minimum 3 years of experience in quality management (including quality documents, training, risk prevention, deviation management, and CAPA), preferably in the pharmaceutical industry.
- Experience in preparing for and hosting GMP inspections is an asset.
- Proficiency in English, good knowledge and practical experience of Microsoft Office.