Work Schedule
Other
Environmental Conditions
Office
Job Description
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
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Position Summary:
To generate 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. Collaborate with the Packaging Client Services to assist with defining client requirements for batch documentation, and to advise on standard processes.
Responsibilities:
- To collaborate closely with other teams to enable the creation of project documentation and to ensure it proceeds in a timely and controlled manner
- Generation of Production orders in ERP system (GPM) and associated documents
- Generation of Label Print orders in ERP system (Clinical Labelling system) and associated documents
- Participate in pre-operations meetings ensuring that the technical specifications 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
- Find 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
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.