Jobdescription
Your Role
* Maintain theQuality systems strategy and relatedSOPs
* Ensure that the relevant procedures areimplemented and periodically reviewed, as well as monitor andimplement best practices andlegislations.
* Support continuously improve theQMS related to her areas of responsibility and coordinate relevanttraining activities.
* Collaborate with theOperational teams to ensure that all the activities meet qualityspecifications.
* Participate to and approve therisk assessments related to her areas ofresponsibility.
* Support the quality review andapproval of Documentation system.
* SupportHealth Authorities inspection, internal and/or external audit, andsupport the evaluation and execution of actions with the GlobalResponse Team (GRT).
* Ensure the training forother quality systems as a back-up (if applicable) to ensure theflexibility of the overall QMS team
Qualifikationen
Your Profile
* Minimumbachelor's degree in a scientific discipline and 2-5 years ofexperience in a pharmaceutical/biotechnologyenvironment.
* Experience in establishing orimproving QMS systems as an operationalSME.
* Basic knowledge of Health Authorityregulations.
* Experience in the usage of ITsystems (CARA, TW, GxP Manager, GLIMS, SAP Leanetc.)
* Excellent communication skills, flexibleteam player, curious to learn, and proactive in sharing andcollaborating.
* Analytical and problem-solvingabilities, as well as proactive approach to all aspects ofquality.
* Organized and logical in definingworkload and delivering project
* Fluency inEnglish is mandatory; knowledge of French is aplus.