Change Control ManagerChange Control Manager - Project management/ SAP / GxP /RotkreuzBackground:Global External Manufacturing is the competence center for parts and products in the diagnostic workflow, manufactured by external suppliers. This includes the development of new products, product care activities, the assurance of supply as well as the supplier selection and maintenance in close collaboration with Procurement.The perfect candidate is someone who has knowledge and experience in GMP regulations and practices. Furthermore the candidate demonstrates flexibility, adaptability, proactivity and process thinking.Tasks & Responsibilities:Managing change execution and change Coordination in the area of Global External Manufacturing with internal stakeholders (e.g. Quality Management) and external contract manufacturersResponsible for the efficient implementation of changes within Roche and also at the the contract manufacturerResponsible for compliance application of the change and the corresponding KPIsResponsible for maintenance and preparation of the regulatory correct documentation, for example Change Request/ChangeNotification, Design Master Record, Design History File etcPlanning and implementation of projects and work packages from product care projects with minimal supervisionBeing a proactive member of the squadIdentification of process improvements in the working area (e.g. change process)Must Haves:. degree in Engineering, Natural Science or related disciplines or apprenticeship with high degree of subject matter expertiseMinyears of Project management experienceWork experience in change management or in project and process managementPractical experience in a regulated GxP environment, ideally in medical devices/IVD industry (ISO, FDA 21 CFR 820, IVDR/MDR)First professional experience in document management within a regulated environmentGood knowledge in SAP or comparable ERP systemVery good user skills in MS Office and Google applicationsVery good communication skills in German (B2/C1) and English (C1) (spoken andReference Nr.:SBIRolle: Change Control ManagerIndustrie: PharmaWorkplace: RotkreuzPensum:%Latest Possible Start Date: ASAPHome Office: 2-3 days onsitePlanned Duration of Employment: 1 year ++application deadline:Sollte diese Position Ihr Interesse geweckt haben, senden Sie uns bitte Ihr komplettes Dossier via den Link in dieser Anzeige. Falls diese Position nicht so gut zu Ihrem Profil passt und Sie sich wünschen, andere Position direkt zu erhalten, können Sie uns Ihr Dossier ebenso via diese Anzeige oder an jobs[at]itcag[dot]com zukommen lassen.Kontaktieren Sie uns für weitere Informationen über unser Unternehmen, unsere Positionen oder unser attraktives Payroll-Only-Programm: Über uns:ITech Consult ist ein nach ISO 9001:2015 zertifiziertes Schweizer Unternehmen mit Niederlassungen in Deutschland und Irland. ITech Consult ist spezialisiert auf die Vermittlung von IT-Kandidaten für Auftragsarbeiten. Wir wurdenvon IT-Profis gegründet und wissen daher, wie wichtig die professionelle Unterstützung bei der Projektsuche und -arbeit ist. jidbcda6e5a jit0208a jiy26a