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CSV Validation Engineer
Eingestellt von Quanta Consultancy Services
Gesuchte Skills: Engineer
Projektbeschreibung
A pharmaceutical organization, is seeking a CSV Validation Engineer, based in the Netherlands, Amsterdam area.
Project
The organization has a large backlog of validation files which need to be resolved quickly. Mainly within its operations department
Profile
For the execution of the tasks an additional resource is needed to write validation documents and executes the validation tasks.
Activity list:
- Write/Execute/Protocols
- Must be able to carry out validation life cycle
- Functional Specifications
- Technical Specifications
- Unit Testing
- End to End Testing
- URS
- Acceptance Testing
- Validation reporting
Requirements
- Must be English for reading/writing.
- Experienced with medium to complex validation activities.
- Knowledge of regulatory requirements (GMP).
- Knowledge of 21 CFR Part 11
- Knowledge of process equipment is a pro
- Experience with IT-systems and interfaces.
- Identifying and suggesting solutions for problems.
- Good communication and organizational skills.
- Ability to work on different tasks simultaneously.
- At least 4y relevant experience
- Extensive SDLC knowledge
- Experience in writing SOP computerized systems
Start ASAP
Projektdetails
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Einsatzort:
Amsterdam, Niederlande
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik