Quality Management System Expert (m/f)

Description

• Map, restructure and merge the QA processes and Quality documentation (Standards, SOPs) of existing Quality Management systems to ensure compliance with GxPs and to other requirements defined by Regulatory department in order to build one RRP QMS
• Support the development of QC processes and practices related within functional groups
• Develop QA processes and write Quality documents (Standards, SOPs) and Quality Technical Agreements (QTA) to ensure information product consistency (data traceability, integrity, product/material tracking and product history) of RRPs from development to commercialisation and ability to easily retrieve relevant information for regulatory submissions
• Guide and support RRP organisation and actively participate to the implementation of external and internal guidelines and standards defined and/or selected by Regulatory department
• Serve as key contributor for assurance of implementation and training of processes and quality documents owned, written and used by the RRP organisation
• Coordinate activities with teams in charge of the implementation of IT systems supporting QMS in order to ensure timely availability of dedicated systems for transfer of QMS documentation and training records

• Substantial experience in an environment using quality systems (ISO, GxP standards, FDA guidance, ICH guidelines) and preferably in the area of life sciences
• Excellent knowledge of Quality Management systems and standards (FDA, GxP, ISO), very good knowledge of regulatory environment
• General understanding of scientific issues (accomplished level), knowledge of tobacco and reduced risk products including the regulatory environment surrounding these
• Excellent ability to work in cross-functional teams
• Excellent communication skills in English