Investigation Specialist

This role supports processes within operations in the implementation and delivery of good manufacturing processes. This role is a part of the Investigation Team for Operations. This team is responsible for supporting the technical challenges, improvements, investigations for production and sharing standard processes with other teams. Team deliverables:

• Reduction of the Quality critical metrics overdue backlog (DRs, CAPA, CC, DI etc) and ongoing management of Quality important metrics on a timely basis
• Process improvements, cycle time adherence and value stream mapping
• Reduction of recurring DRs (data analysis support to be provided by QA team)
• Positive cultural transformation
• Continued Process Verification
This role supports processes within the operation department in the implementation and delivery of good manufacturing practice from a technical perspective.,
• Complete Deviation investigation and writing Deviation records.
• Implement CAPAs and change control actions.
• Revise, improve and simplify SOPs as needed.
• Maintain focus on a positive critical metric position in operations.
• Highlight training needs to managers as they arise and influence Operations wide learning.
• Utilise PPI tools to drive process improvements.
• Support RAPID Investigation Operations.
• Provide technical support in writing:
• -BSTCC
• -Support deviation investigations
• -Update and create SOP
• -Support BMR updates with technical input
• -Create relevant department specific Change Controls, and present to committee.
• Update and present departmental important metric matrix
• Tracking improvements, preventing troubleshooting solutions to key collaborators.
• Maintaining required housekeeping standards at all times.
Procedures and other documentation:
• Work with employees across the operations to draft, improve and update SOPs, work instructions and other documentation, checking their application in the operational phase.
• Act on the updates to the GMP requirements and assess the need to update procedures another documentation.
• Contribute to BMR improvement by capturing findings, checking their application in the operational phase, and then incorporating them into the BMR.EHS:
• Understand emergency procedures and follow safe systems of work.
• Ensure compliance with environment, health and safety rules, signage, and instructions always.
• Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules.
  
  Working knowledge of the principles and guidelines for GMP as set out in the 'Orange Guide.'
• Understanding of the end-to-end manufacturing process.
• Proactive approach to work, with a willingness to do what needs to be done to deliver against landmarks.
• Pragmatic / common sense approach to problem solving.
• Demonstrable ability to make sound risk-based decisions.
• Excellent interpersonal skills with the ability to appropriately challenge other's behaviours.
• Technical writing skills.
• Good time management skills., Substantial experience working in pharmaceutical manufacturing, with knowledge of sterile filtration, liquid filling components bulk provider manufacturing.
• Skills for, or working knowledge of mechanical and software operation.
• Experience of new facility/process start-up.
• Experience in lean/removal of non-value add from documentation and manufacturing processes desirable.
  
  When you're part of Thermo Fisher Scientific, you'll do exciting work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world., At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
  
  We offer a wide range of flexible benefits in addition to competitive salaries which include pension and healthcare. Does this sounds like a good match for your skills and experience? If so we'd love to hear from you!