Quality Assistant

Job Description

The Quality Assistant is the local and global support for all quality matters including implementation of quality procedures, standards and specifications across all activity, auditing to ensure compliance and making sure corrective actions are taken to minimise future occurrences.

Responsibilities

• Implementing global Quality Assurance strategy locally that outlines goals for activities such as building effective Quality Assurance procedures, audit standards and ensuring consistent application, making sure appropriate corrective actions are carried out to minimise future occurrences.
• Implement local P, SOP, WI, SF and other documentation that provides guidance and clarity on procedures concerning clinical trials logistics.
• Ensure that all operations are performed according to the applicable standard procedures and working instructions in the Hungary Warehouse.
• Ensure improvement of effective Quality systems and procedures locally.
• Participate in review of local and global Standard Operating Procedures, Work Instructions, Standard Forms, and other documents.
• Maintain Quality Management System documentation in electronic and paper form.
• Informing Hungary personnel about new documents issue / documents update.
• Conduct Quality Management System trainings : procedures, GxP trainings, onboarding trainings locally .
• Lead Client’s external audits, providing documentation required during external audits and assessment, providing response concerning observations occurred during external audit.
• Ensure that all operations are performed according to the applicable standard procedures, working instructions, ISO 9001, GxP requirements, local and global legislation requirements.
• Prepare Suppliers audit schedules and assist in audits of Suppliers, preparation of audit report and control of Corrective and Preventive Actions implementation.
• Participate in Management Review process, preparing reports on functioning of QMS processes and its effectiveness for Hungary Warehouse.
• Assist and participate in non-conformities investigations.
• Prepare internal audit schedules, conduct internal audits and preparation of internal audit reports.
• Control of timely closure of Corrective and Preventive Actions .
• Ensure timely completion of trainings assigned to Quality Officer.

Authority

Requirements

Qualification

Experience

Skills, Knowledge, and Special Qualities