Ihre Aufgaben:
* Accountable for local CSV & Quality deliverables defined for the local Deployment
* Definition of local Change Request/Validation/Implementation plans (incl. CSV) and related closure/reports
* Accountable for the local implementation plan, local implementation interim report, local implementation report according to CSV requirements and the respective SOPs
* Coordinate and support adoption of local SOPs (i.e. definition of the SOP inventory, planning of SOP updates and coordination of SOP updates according to plan)
* Supporting the training activities as well as test planning, execution, closure and defects
* Supporting data migration, esp., local verification and incidents associated with GxP data
* Supporting local cutover activities to ensure all protocols are completed and deviations accepted
* Supporting any definition of interim ways of working required during cutover
* Defining and supporting any PQ activities if required
* Compliance support for defects, incidents and change controls
* Coaching and training of local project team as required in related compliance approaches/deliverables
* Accountability for compliance, quality assurance, deliverable acceptance, and sign-off processes within the project
Ihre Qualifikationen:
* Master Degree: A successfully completed engineering degree in the field of biotechnology, process engineering, mechanical engineering, electrical engineering or automation technology
* Manufacturing/GxP validation responsibilities
* Profound experience in quality management in the technical and CSV, qualification fields
* Extensive experience in the regulatory requirements in the GMP environment
* Knowledge of compliance work within a project/change environment
* Understanding of ERP life cycle, deliverables and the compliance needs/implications
* Previous deployment of global application to site highly advantageous
* Very Good x-functional understanding of compliance within a manufacturing site
* Ability to work in a matrix environment
* Experience in controlling/developing compliance deliverables and supporting other streams as appropriate
* Ability to work within a multicultural environment
* Fluency in English and German (written/spoken)
Ihre Vorteile:
* Interesting and responsible tasks in a multinational environment
* Remote work possible (30%)
* Long project duration planned