Role DescriptionAs Quality Assurance Manager and Qualified Person you are responsible for the business unit that manufactures and controls drug substances and related final products. Your main responsibility will be to implement, maintain and manage a GMP compliant Quality Management System. You will report directly to the Quality Assurance Director.
Responsibilities- Manage the QMS of drug substances and related final products; - Manage the CAPA system: changes, deviation, non-conformities; - Manage, support and coordinate risk assessments; - Manage the supplier qualification process (materials and services); - Support and review the qualification of production equipment, test equipment and cleanroom facilities; - Lead audits and inspections; - Review and approve batch records; - Release batches of intermediate products, drug substances and related final products; - As a Qualified Persons, certify final products; - Promote GMP-awareness.
Requirements- A Master of Science degree in a scientific discipline; - You are a registered QP - 5-10 years of quality assurance experience in pharma or biotech; - Knowledge of GMP quality systems - Fluent in Dutch and Englishn.
Other informationOur client provides: - a position with responsibility within a dynamic company; - an envrionment where professional and personal development is supported; - a salary, depending on your experience, based on market practice.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.