Work Schedule

Environmental Conditions

Job Description

When you’re part of Thermo Fisher Scientific, you’ll do challenging 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 $20 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.

Position Summary:

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.

Key responsibilities:

• 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.

Minimum Requirements/Qualifications:

• 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.

Desirable qualifications:

• 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.