QMS Engineer (m/f)

REFERENZNUMMER:

310526/11

IHRE AUFGABEN:

-Participate in the development of the Reduced Risk Products (RRP) Quality Management System (QMS)
-Actively implement the QMS documentation with different functions of the organisation
-Ensure that the quality requirements of the RRP QMS are integrated into and addressed within the RRP organisation
-Ensure that all newly defined and developed elements including IT systems for quality management are integrated and introduced into the new QMS
-Write, update and review quality documentation (standards, SOPs, WKIs) of quality management systems in order to ensure compliance to GxPs and to other requirements defined by the regulatory department in order to build one RRP QMS
-Assist in the RRP organisation and actively participate in the implementation of QMS documents in EDMS (Electronic Document Management System)
-Serve as a key contributor for assurance of the implementation and of the training processes that are IT systems related (document management and training management), quality documents owned, written and used by the RRP organisation

IHRE QUALIFIKATIONEN:

-Profound experience in the quality systems environment (ISO, GxP standards, FDA guidance, ICH guidelines) and preferably in the life sciences area
-Very good knowledge of quality management systems and standards (FDA, GxP, ISO)
-Excellent expertise in writing quality documentations (standards, SOPs, WKIs)
-Excellent expertise in IT systems used for QMS documents management and for training management
-Knowledge of and expertise in IT systems for non-conformity, CAPA and audit management is beneficial
-Excellent ability to work in cross-functional teams
-Excellent communication skills and written English skills

WEITERE QUALIFIKATIONEN:

Quality manager