1. Drive project management and project execution, including deliverables for AP Module within IT&Automation context are delivered according to plan and within budget.
2. Leadership and managing the AP Automation organisation.
3. Ensure close collaboration between FFEx STJ AP Automation, FFEx IT&Automation and STJ local DD&IT.
4. Quality and compliance
1. Drive project management and project execution
? Assumes accountabilities for all IT&Automation activities of the AP Module in STJ FFEx facility.
? Provides clear goals and purpose for the AP Automation area and the project team members so that the project secures effective use of time and resources and builds employee motivation.
? Actively participate in the creation and develop of the project plan with effective and transparent systems, structures, and processes
? Prepare budget for AP Automation activities and actively participate in the monitoring and control of the project work with stringent follow-up on quality, schedule, and budget so that the project delivers the desired end-product
? Together with FFEx IT&Automation and FFEx STJ project management create, develop, and drive the FFEx IT&Automation scope for AP Module
? Lead deployment of validation strategy and performance of AP Automation systems
? Escalate in case of issues/delays
2. Leadership and managing the AP Automation organization team
? Build organization and lead recruitment of professionals towards operational excellence
? Ensure that the right number of resources and competences is allocated to the project, negotiate project resources with LoB management and manage these resources during project execution
? Responsible for the members of the team, ensuring that responsibility and roles, tasks and interfaces are clearly defined and understood by the whole team
? Daily leadership: Feedback and coaching of employees at the shopfloor
? Ensure that the Performance Board and process confirmation is carried out in a structured way
? Ensure development of people
? Hold timely and well-prepared talks with employees (One Review, IDP etc.)
3. Ensure close collaboration between FFEx STJ AP Automation, FFEx IT&Automation and STJ local DD&IT.
? Actively collaborate with FFEx in the development and implementation of requirements, equipment and procedures in the AP module and facility
? Ensure close collaboration between the different stakeholders in FFEx STJ IT&Automation, FFEx STJ AP Process and STJ local DD&IT
? Responsibility to secure standardisation in design and execution as aligned with the FFEx IT&Automation
4. Quality and compliance - Lead the area in ensuring that:
? Internal and external quality and legal demands are in compliance with cGMP
? The area fulfils any legal demands and are working according to current GMP-/ISO/ FDA/EMEA/QSR regulations and have the right Quality Mindset
? The area is always ready for audits and inspections
? The team will follow current SOP’s
? All employees have documented correct training in ISOtrain in accordance with their tasks
Education 教育背景
? PhD, Master or Bachelor of Science, Engineering, or Finance/IT
? Preferably People or Project Management training/certification
? Solid GMP training