Work Flexibility: Hybrid
Who we are looking for:
The Senior Project Manager will be the primary contact between sterilization and batch release team and suppliers in The Finished Goods Operations. This person will provide expert project planning and quality system support, in ensuring goals and objectives are achieved for GSE.
What you will do:
- Establish detailed planning for the sterilization and batch release expert needs
- Complete document updates in the several quality management systems
- Continuous improvement and development of organization and internal project activities in The GSE sterilization and batch release team.
- Introduction of best practices in project management and supplier communication.
- Co-ordinate with business units to ensure that batch release and sterilization requirement are appropriately carried out.
- Ensure that a consistent approach in the team is developed and maintained.
- Co-ordinate with the business units in relation to non-conformance activities and root cause to ensure a consistent approach.
- Provide effective and responsive project and QMS support to Operations to resolve in-house, customer and supplier issues.
- Own and review NC/CAPA’s related to process.
- Interface with Suppliers for planning/quality Issues.
- Work cross functionally with such groups as Regulatory, Design Division and Operations to ensure all issues are successfully resolved.
- Support The Finished Goods Operations in addressing quality metrics, e.g. NC, CAPA, Process Changes, , Quality Alert, Product Holds and Recalls.
- Support site during External Audits. (i.e. FDA, IMB and BSI).
- Responsible for input to Quality Metrics.
- Ensure quality system updates
What you will need:
- Degree Qualified preferable
- Minimum of 2 years experience in a Project Management role
- Minimum of 2 years’ experience in a Quality system role is a plus.
- Good level of analytical skills.
- Problem Solving Skills and ability to handle multiple tasks in a fast-paced environment.
- Capable of working as part of a multi-discipline team across multiple continents and time zones.
- Competent in working with all Microsoft Office programs (Excel, PowerPoint & Visio etc).
- The individual should be able to show rigor and structured approach
- Excellent Communicator.
Travel Percentage: 10%
Read Full Description