Expert in Computer System Validation
vor 4 Wochen
As a Computer System Validation Expert at Siegfried, you will be responsible for ensuring the quality and integrity of our computerized systems. Your role will involve planning and executing validation activities, creating documentation, and summarizing data and results in report form. You will also be responsible for introducing new computerized analytical instruments in the laboratory and supporting colleagues with on-site commissioning.
Key Responsibilities- Ensure the smooth operation of computer system validation and qualification in accordance with current regulations.
- Be the primary point of contact for all questions related to validation and qualification processes.
- Manage the entire CS validation process.
- Conduct final evaluations of validation data and prepare reports.
- Participate in technical projects involving CSV activities.
- Provide first-level support and administration of complex IT systems under GMP.
- Coordinate external service providers in case of system malfunctions, EDV introductions, system updates, or changes.
- Bachelor's degree in natural or engineering sciences, preferably in process engineering or electrical engineering.
- Familiarity with current GMP requirements and guidelines for computer system validation (CSV) such as Annex 11 of the EU GMP Guide and GAMP.
- Desirable experience in qualification and validation, preferably in the CSV/Data Integrity area.
- Strong GMP and quality awareness, as well as precise and meticulous working habits.
- High organizational skills, independence, and result-oriented working style.
- Good communication skills, enjoyment of collaboration and cooperation between different departments.
- Proficient use of MS Office applications.
- Good English skills in writing and speaking.
Siegfried's work environment is dynamic and international. With a highly professional and motivated team, the company operates in a future-oriented business field. Siegfried possesses a unique culture that leverages cultural differences to create a competitive advantage. Siegfried places highest priority on providing a flexible, diverse, and discrimination-free working environment in which employees can develop personally and professionally, advance innovation, and deliver superior performance.
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Expert in Computer System Validation
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