Main Duties and Responsibilities:
- Map As-Is business process, including RACI, business rules, and role-based storyboards
- Develop Could-Be processes, by phase with target metrics
- Develop To-Be processes, by phase, including RACI, target metrics and role-based storyboards
- Develop system requirements for the To-Be process - linked to steps in the business process
- Ensure all process developments and improvements meet the Quality Management System requirements as defined by the Client e.g. ISO 13485, FDA, ICH etc.
- Strong analytical approach to problem solving to deliver innovative solutions.
- Engage with the appropriate personnel in the identification and resolution of
- Corrective/Preventative actions to address Quality, Technical, and Manufacturing issues (Audit Actions, NCR's, CAPA's, etc).
- Project Management - Accurate planning, timely delivery and reporting for all project deliverables.
- Participate in risk, qualitative and quantitative assessments as required.
Required Skills and Experience
- BPM/BPMS certification or Six Sigma certification, or Quality Management Systems certification
- Proven experience in use of the DMAIC process improvement methodology
- Proficient in the use of the Nimbus BPMS
- Clinical Trial process knowledge and experience
- Relevant experience with statistical process control and capability analysis required.
- Excellent analytical and problem solving skills, root cause analysis and risk assessments with a strong attention to detail.
- Experience of lean concepts applied to IT systems and standard work would be an advantage
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales