Quality System Management Leader
il y a 4 jours
**Main Responsibilities & Tasks**:
- Drive the consistency and the compliance of the Quality System by implementing: adequate documentation, meaningful KPI, internal audit plan, cross audits between sites, between operational units efficient CAPA management.
- Be the partner and the relay of sites and global QMS functions (named BPS)
- Use the network to create synergies, to share best practices, to share audits observations, to improve and continue to build harmonization.
- Drive creation, review and implementation of common documents
- Support internal, external audits related to his/her scope of expertise where appropriate
- Support the development of the risk management
- Improve training system and efficiency
- Assure Data Integrity for CCM sites
**Profil required**:
- Master degree in Engineering or biotechnology
- Min. 7 years’ experience in production or in engineering center - industries targeted biotech, pharma, API/Excipients manufacturing, culture media.
- Strong GMP, Medical device & industry standards knowledge ( 21 CFRs/ ISO13485/ ICH Qs, )
You already implemented or participated to the implementation of a QMS and drove (or be part of) a quality management system in pharmaceutical industry and/or in an ISO 13485 environment.
You are pragmatic and give sense to your choices. You quickly create good human relationships. You are able to constantly adapt yourself, to work in a matrixial environment and to shape the future.
You want to be part of a dynamic company where quality is a key objective. You want to work for customers manufacturing medicines. You want to be part of a multi-cultural team over the world and be ready to travel in US, Europe and Asia.
We look for employees who would like to grow with us and move the innovative life sciences sector forward. In the process, we focus on agile project work, mutual support within teams and working as equals. Sartorius thrives as a company with people who give their very best every day and who are eager to develop personally and professionally.
Further insights into our world of work can be found here.
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