QA Engineer (m/f)

Description

• Participate in the development of the Reduced Risk Products (RRP) Quality Management System (QMS)
• Preparation and review of QMS documents for transfer in template and in IT systems
• Ensure that the quality requirements of the RRP QMS are integrated into and addressed within RRP organisation, and that all newly defined and developed elements including IT systems for quality management are integrated and introduced into the new QMS
• Write, update, review Quality documentation (Standards, SOPs, WKIs) of Quality Management Systems in order to ensure compliance to GxPs and to other requirements defined by Regulatory department in order to build one RRP QMS
• Support RRP organisation, actively participate in the implementation of QMS documents in eDMS (electronic Document Management System)
• Act as key contributor for assurance of implementation and training of processes, IT systems related (Doc management, Training management) and quality documents owned, written and used by the RRP organisation

• in-depth experience in an environment with quality systems (ISO, GxP standards, FDA guidance, ICH guidelines) and preferably in the area of life sciences
• Very good knowledge of Quality Management Systems and standards (FDA, GxP, ISO) Knowledge of tobacco and reduced risk products including the regulatory environment surrounding these is of advantage
• Excellent expertise in writing Quality documentation (standards, SOPs, WKIs)
• Excellent expertise in IT systems used for QMS documents management and for training management Knowledge and expertise in IT systems for Non-Conformity & CAPA and Audit Management is of advantage
• Excellent ability to work in cross-functional teams.
• Excellent communication and written skills in English