Expert in Computer System Validation

vor 4 Wochen

Minden, Nordrhein-Westfalen, Deutschland Siegfried Vollzeit
Your Role

As a key member of our team, you will be responsible for ensuring the GMP-compliant qualification of computerized systems in accordance with the current regulatory guidelines. This includes planning and executing qualification processes, creating relevant documentation, and summarizing qualification data and results in report form. You will also be responsible for the qualified introduction of new computerized analytical instruments in the laboratory and supporting colleagues with on-site commissioning. Additionally, you will support the technical departments in the areas of CSV and data integrity.

Key Responsibilities
  • You are responsible for the smooth execution of qualification and validation processes for computerized systems in accordance with current regulations.
  • You are the first point of contact for all questions related to qualification and validation processes, and you manage the entire CS validation process.
  • The final evaluation of validation data and report creation are also part of your tasks.
  • You will be involved in technical projects that include CSV activities.
  • First-level support and administration of complex IT systems under GMP, as well as local support for the LIMS, are also part of your responsibilities.
  • You will coordinate external service providers in the event of system malfunctions, EDV introductions, system updates, or changes.
Your Profile
  • Completed (bachelor's) degree in natural or engineering sciences, preferably in process engineering or electrical engineering.
  • Familiarity with current GMP requirements and guidelines for the validation of computerized systems (CSV) such as Annex 11 of the EU GMP Guide and GAMP.
  • Desirable experience in the areas of qualification and validation, preferably in the CSV/Data Integrity area.
  • Well-developed GMP and quality awareness, as well as precise and meticulous working methods.
  • High organizational skills, independence, and result-oriented working methods.
  • Good communication skills, enjoyment of cooperation and collaboration between different departments.
  • Proficient use of MS Office applications.
  • Good English skills in writing and speaking.
Working at Siegfried

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. We strive to provide a work environment where employees can take on challenging jobs and associated responsibilities that best serve their personal and technical development and can benefit from the success of our company. The company regulations in respect of compensation and career development opportunities apply to all Siegfried sites. Additional conditions of employment are governed by location-specific circumstances, legislation and customs.

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