Archiviertes Projekt - Computerized System Validation Expert (m/w/d)
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For my client I'm currently looking for a Computerized System Validation Expert (m/w/d)
* Active support in the conception, implementation and operation of validation measures along pharmaceutical processes and taking into account quality, cost and timeline requirement
* The integration of stakeholders from different functions and 3rd parties is part of your tasks
* Participate as SME to the URS preparation: You support the project team in the analysis of customer requirements and the creation of solution concepts for later implementation and changes
* Perform impact and risk assessments, design and prepare qualification / validation documents (incl. test management)
* Maintain the validation status of existing computerized systems according to a predefined frequency and in accordance with current internal SOPs
* Ensure compliance of the validation standards of the computerized systems through the continuous updating of procedures, according to international regulation and standards (GxP, GAMP5)
* Create and maintain of Qualification documents (Network, Servers, Operating Systems, Databases) and oversee end-to-end process enforcement in the GxP environment
* Ensure Infrastructure (Network, Servers, Database) Qualification documents are created, updated and reviewed on the defined Quality standards and on time on the regular bases
* Several years of professional experience in computerized system validation (CSV) in several projects
* Experience in the development of validation plans and their implementation and know how to find and implement viable solutions in an environment of competing interests
* Practical experience in the application of relevant regulations (EMA, FDA, OECD etc.) and know how to derive practicable measures according to GAMP5
* Good understanding of GAMP processes
* Experience in information security (e.g. ISO27001) and cybersecurity risk management is a plus
* Ability to write clear documentation and communicate complex information simply and accurately to both technical and non-technical audiences
If you are interested in the vacancy Computerized System Validation Expert (m/w/d) then do not hesitate:
Send your CV. Please also include your name with your application:
* your availability,
* Your experience with the above mentioned requirements
* Your hourly rate and
Please also note that we can only consider complete applications.
I look forward to your feedback.
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