What are your responsibilities?

As QA Officer, you are in charge to

• Maintain a batch certification register EU import of IMP and batch certification & release of medicinal products.
• Develop and establish the administration of effective quality systems, practices and procedures, while coordination activities relative to quality systems, quality improvement to ensure compliance to quality standards.
• Assist and support of QA Manager.
• Cultivate integrated working relationships with employees and other departments to maintain and foster quality standards.
• Support to the compliance of the site's systems of handling, manufacturing and distribution of Investigational pharmaceutical products.
• Support that services are delivered on time and according to the agreed quality standards.
• Maintain a timely and effective communication and escalation process exists to raise quality issues to Executive Committee.
• Monitor permanently the regulatory requirements (like GMP Guidelines, legislation in terms of IMP manufacturing activities).
• Support C-GMP met through training and perform internal audit.
• Manage, prepare, host, follow-up customer audits. Perform and contribute to manage Supplier qualification, Audit, co-ordinate and supervise third parties.
• Work within and contribute to assurance of an up-to-date quality management system in compliance with current legislation and customer requirements and contribute to ensure full awareness.
• Participate to the appropriate interfaces to support improvement of the Quality System and ensure exchange of knowledge.