Beschreibung
Computerized System Validation Expert (m/w/d)For my client I'm currently looking for a Computerized System Validation Expert (m/w/d)
Your Responsibilities:
- 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
Your Requirements:
- 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 by mail to d.rychel[at]computerfutures.de Please also include your name with your application:
- your availability,
- Your experience with the above mentioned requirements
- Your hourly rate and
- References
Please also note that we can only consider complete applications.
I look forward to your feedback.