Csv Specialist

6 giorni fa

Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale.
Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer
We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
**CSV Specialist - Maternity replacement (12 months fixed term contract)**:
Guarantee, under the Automation Engineering & CSV Manager supervision, that all Information Systems used at Patheon Monza facility are compliant to the Italian, European and American guidelines (NBF/EU Annex/GMP).
**Main responsibilities**:
- Assure the execution of the validation projects, within the timeline and the modality defined upon the priorities by the site management.
- Edit and review validation documents (specification documents, risk analysis and validation protocols) in agreement with the site procedures.
- Collaborate with other functions of the site and external contractors to complete the validation tasks, in compliance with the internal and external guidelines.
- Ensure that the validation documents issued by supplier and contractors are compliant to the quality standard.
- Collaborate with the definition of standards to ensure the validation of the computerized system in agreement to the local and corporate guidelines.
- Issue and update the local procedures aligned to the guideline and the corporate standards
- Coordinate contractors and suppliers for the completion of the validation projects and all related activities.
- Cooperate with external functions to improve the quality culture to keep the validated status of the computerized systems.
- Collaboration with the following internal areas: Manufacturing and maintenance area; QA/QC; Logistic; IT, Data Integrity
- Coordination of Validation contractors and software and equipment suppliers
**Education and experience**:
Computer Science/Scientific Degree
GMP/GAMP knowledge
Word, Excel, MS Project
Ideally previous experience in information systems validation
Please note this is a **12 month fixed term contract** for a maternity replacement.
As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, tackle complex scientific challenges, drive technological innovation and support patients in need.
#StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
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.

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