Expert in Computer System Validation
vor 4 Wochen
As a Computer System Validation Expert, you will be responsible for ensuring the compliance of computerized systems with regulatory requirements. Your role will involve planning and executing validation activities, creating documentation, and summarizing qualification 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. Additionally, you will support the technical departments in the CSV and data integrity working field.
Key Responsibilities- Ensure the smooth operation of qualification and validation of computerized systems in accordance with applicable regulations.
- Be the first point of contact for all questions related to qualification and validation processes, manage the entire CS validation process.
- Conduct final evaluations of validation data and prepare reports.
- Participate in technical projects that include CSV activities.
- Provide first-level support and administer complex IT systems under GMP, as well as local support for the LIMS.
- Coordinate external service providers in case of system malfunctions, EDV introductions, system updates, or changes.
- Bachelor's degree in natural or engineering sciences, preferably process engineering or electrical engineering.
- Familiarity with current GMP requirements and guidelines for computer system validation (CSV) such as Annex 11 from the EU GMP guide and GAMP.
- Desirable experience in qualification and validation, preferably in the CSV/data integrity field.
- 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. 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.
About UsIn the Midst of People's Lives – Across the GlobeThe Siegfried Group is one of the world's leading Custom Development and Manufacturing Organizations (CDMOs) developing and producing active pharmaceutical ingredients (API), intermediates, and finished dosage forms. As our core competence, we successfully integrate chemical and pharmaceutical capabilities into a single business model. The Siegfried name stands for highest quality, efficiency, flexibility, and safety. Present in Europe, Asia, and North America, we serve a broad global customer base from major international pharmaceutical companies down to small biologic-pharmaceutical organizations. For them, we develop and produce product innovations on a large scale to finished products. We integrate our offer seamlessly into the customers' value chain. Our comprehensive services range from early-stage Research & Development services such as synthesis, scale-up, formulation development, stability studies, and method development all the way through to manufacturing services, ranging from preclinical R&D material for clinical trial purposes to commercial production. We are able to produce about 200 of the approximately 1500 registered drug substances used in medicine. Moreover, we produce 20 percent of global demand for caffeine. Consequently, nearly 1 billion individuals come into contact with Siegfried products.
What We Do in MindenFor the last 80 years, Siegfried PharmaChemikalien Minden GmbH has been producing active pharmaceutical ingredients (APIs) and the corresponding intermediates at its Minden facility, to meet worldwide demand from the pharmaceutical industry. We also produce ingredients for the cosmetics and food industries.
Main activities
- Development and commercial manufacture of active pharmaceutical ingredients (APIs) and corresponding intermediates
- Fully compliant with cGMP and SHE (Safety, Health and Environmental) standards
Special features
- Handling of high potency substances in development and production
- Comprehensive handling of solids in production
- Production capacity: 1450 m3
- Reactors: 0.2–30 m3
- Handling of highly toxic substances in encapsulated plants
- Successful transfers of new products into commercial production
- Biotechnology implementations
Strategic importance
- Contract manufacturing of new active ingredients
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