Project Support Associate
Vor 7 Tagen
**About Thermo Fisher Scientific**
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $40 billion and approximately 110,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands - Thermo Scientific. Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services - we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive service.
**Location/Division Specific Information**
The Project Support Associate - Documentation Specialist generates batch documentation in accordance with Thermo Fisher SOP’s, GMP and GxP Guidelines and client requirements.
The documents include the instructions for manufacturing, blinding and packaging of clinical study material itself, but also the compilation of the variable data for label printing.
You will collaborate with the Packaging Client Services to assist with defining Client requirements for batch documentation, and to advise on best practice.
**Responsibilities**:
- To liaise with Packaging Client Services Project Managers, Quality, Packaging Design and Operations where appropriate to enable creation of project documentation and to ensure it proceeds in a timely and controlled manner in line with project and process requirements.
- Generation of Production orders in ERP system (GPM) and associated documents including change orders, in conjunction with the information provided by the Packaging Client Services.
- Generation of Label Print orders in ERP system (Clinical Labelling system) and associated documents in conjunction with the information provided by the Packaging Client Services.
- Participate in Pre-Operations Meetings ensuring that the technical specification and possible operational challenges of new projects are discussed and resolved at an early stage. Attend Close out meetings to review the success of projects and participate in continuous improvement opportunities where appropriate.
- Manage online operational issues and resolve challenges to ensure that operations continue with minimum disruption.
- Understand and follow all job relevant Thermo Fisher Standard Operating Procedures.
- Act as the SME for the ERP system (GPM) users for the Client Services department ensuring that GPM issues are investigated and resolved quickly in conjunction with GPM super users and the IT dept.
- Manage documentation administration tasks where appropriate to facilitate the documentation process
- Identify opportunities for process improvements beside others to improve and revise Thermo Fisher Standard Operating Procedures.
Minimum Qualifications:
- Bachelor’s degree or equivalent education, ideally in pharma or commercial environment
- Organisational talent & motivated & independent
- Excellent grammar and writing skills
- Proficient computer skills
- Work in a fast-paced environment
- Good written and spoken English knowledge
Preferred Qualifications:
- Experience in pharma industry, commercial operations, quality and GMP skills
- Experience in technical writing
- Customer service experience
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