Leadership of Manufacturing (MFG) electronic systems’ support, change management, digitalization & continuous improvement, in the role as a key interface to other departments and lead or coordinator of cross team activities.
Delivering highest quality products on-time, in-full is the most important responsibility of the MFG team and the Shop Floor management & digitalization team will provide support/solutions which enable/assist the functional leads in data-driven decision making, provide a more in-depth understanding of performance, hence allowing a smoother running of the production processes.
Main Tasks & Responsibilities
- Lead a team providing technical support in the development and continuous improvement of electronic solutions to enable paperless manufacturing of medical device products (for example; performance analytics and monitoring, equipment maintenance, manufacturing instructions and batch record review and release).
- Based on MFG needs across the site, challenge the requirements, prioritize the development of digital solutions, and push the relevant project go-live.
- Provide ERP system support (SAP) including creation and management for master data, weighing system, SAP training & troubleshooting, including but not limited to; Material Master ; IPC inspection plan; Productive and Customs BOMs; Process Instruction (PI) Sheets, Master recipes & Production version and X-Step PI parameters
- Monitor, define and support electronic Batch Record Review (eBRR). Support MFG leads to identify KPIs and develop solutions to track performance in support of MFG shop floor control
- Analyze MFG related “Big Data” and develop data visualization to focus continuous improvement efforts
- As a MFG partner, closely cooperate with Material Management, Quality and other teams on-site for the coordination of internal MFG, cross functional & dual site changes
- As a Local Change Requestor (LCR) and coordinator, interface and collaborate with Site/Global IT application owners and be responsible for MFG Master Data and roll-out for changes and solutions in Suzhou and across other Roche sites
Qualification Requirements: 资质要求
- Bachelor’s degree in informatics or equivalent degree
- 8+ years of working experience with SAP, a GMP/Healthcare background is a plus. Familiar with Digitalization project and Big data analytics
- Project Management execution as leader and team member
- Understand delivery and acceptance of fast-paced project execution
- Demonstrate capability for problem solving, assertive decision making and sound judgement
- Excellent oral and written English
- Communicate, inform and collaborate within stakeholders as a key decision maker and people leader
- Lead in the area of special improvement projects, harmonizing common practices across Roche manufacturing areas and in collaboration with relevant stakeholders and decision makers, especially MSAT, R&D & Quality
- Coordination, management and implementation of respective training programs
- Comply with ISO 13485 as well as local regulatory requirements in order to ensure the right to operate.
- Ensure that all applicable Safety, Health & Environment requirements are fulfilled to comply with corporate group policy and local legal requirements
- Ensure compliance with Roche’s Group Code of Conduct.
Roche is an equal opportunity employer.Manufacturing, Manufacturing > General Manufacturing