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Quality Assurance Manager
il y a 1 mois
About the Role
AUROBAC THERAPEUTICS is seeking a Quality Assurance Manager to join our team. As a Quality Assurance Manager, you will be responsible for implementing and maintaining our Quality Management System (QMS) in line with our quality policy. You will also contribute to our continuous improvement approach by conducting audits and quality controls of our internal processes.
Key Responsibilities
- Develop, maintain, and continuously improve our QMS.
- Draft and/or check procedures and other QMS documents.
- Distribute created/revised QMS documents to relevant employees and manage associated awareness and training actions.
- Initial QMS training for new employees.
- Coordinate and follow-up of periodic reviews of QMS documents.
- Centralize and process requests for continuous improvement, non-conformities, and complaints.
- Update and monitor the implementation of the corrective and preventive action plan (CAPA) in collaboration with operational teams and third parties.
- Update the annual QMS action plan and regular reporting on progress.
- Participate in the preparation of quality management reviews.
Requirements
- Solid knowledge of quality assurance standards (e.g. ISO 9001) and GxP regulations applicable to drug development in an international environment (e.g. GCP, GMP, GLP, GCLP).
- In-depth knowledge of R&D processes (preclinical and clinical stages prior to drug registration) and the players involved.
- Good document management practices.
- Proficiency in audit techniques.
Preferred Qualifications
- Junior-level position; 1 to 3 years' experience in managing a quality documentation system in the pharmaceutical R&D sector would be a plus.
What We Offer
- A competitive salary and benefits package.
- The opportunity to work with a dynamic and innovative company.
- A collaborative and supportive work environment.
