Role DescriptionIn this role you will be responsible for all QA activities in the company and report to the global Quality Director.
Responsibilities- Leading and participate in quality assurance issues; - Be responsible and participate in GMP compliance audits; - Collaborate with other departments (R&D, QC) to improve compliance with quality systems, internal SOPs and regulatory requirements and to resolve deviations & CAPA’s. And departements RA, clinical and non-clinical to ensure the appropriate document/data integrity for regulatory submission and preparation; - Lead or support Document Control related processes; - Support and conduct training for employees, as necessary. - Be responsible for preparing trend reports related to in-process monitoring, deviation reports, investigation reports; - Be the QA representative on project teams and for other departments; - Evaluate compliance of completed Manufacturing records.
Requirements- Scientific Master degree in the Life Science, approx.10 years of relevant experience - Proven knowledge of GMP within the pharmaceutical environment - Experience with regulatory inspections - People management experience - Negotiation and excellent communication skills - Excellent English and French knowledge (oral and written)
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Laura Hoekstra.