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Quality Assurance Specialist
vor 2 Monaten
Daiichi Sankyo Europe GmbH is seeking a committed Quality Assurance Specialist for their Engineering and Pharmaceutical Production/Qualification Group.
Position Overview:
As a Quality Assurance Specialist, you will play a crucial role in ensuring compliance and quality standards within our operations. Your responsibilities will include:
- Strategically planning, overseeing, and engaging in qualification initiatives and projects from a quality management perspective in collaboration with various departments.
- Evaluating and endorsing qualification documentation, including operational guidelines, master plans, testing strategies, test protocols, and reports, while actively participating in their execution.
- Ensuring the sustained maintenance of qualified statuses.
- Acting as the quality management representative in the deviation system: coordinating the resolution of Quality Events in the production and testing of pharmaceuticals, as well as in technical domains.
- Participating in computer validation initiatives within the Quality Management division, preparing lifecycle and testing documentation.
- Providing administrative support for quality management databases and conducting training sessions for all relevant departments across the European Headquarters and affiliates.
- Regularly compiling necessary quality management reviews.
- Assisting the supervisor in quality management-related tasks as required.
Qualifications:
- A degree in a natural science discipline related to Life Sciences (e.g., Pharmacy, Biotechnology, Food Technology, etc.).
- A minimum of three years of experience in Quality Management within the pharmaceutical sector.
- Extensive experience and knowledge in the qualification of equipment and IT systems in the pharmaceutical field.
- Familiarity with technical and production environments in the pharmaceutical industry is advantageous.
- In-depth understanding of national and international GxP regulations.
- Proficient in electronic data processing tools (MS Office, SAP, S4HANA, Trackwise Digital).
- Excellent command of both German and English, both written and spoken.
- Capability to work collaboratively across disciplines and internationally.
- A structured and independent approach to work.
- A reliable, responsible, and meticulous work ethic.
Why Choose Us:
At Daiichi Sankyo, we believe that working with us is more than just a career - it’s a chance to make a meaningful impact on patients' lives. We are committed to fostering a culture of respect and continuous learning, characterized by diversity and inclusion. Here, you will have the opportunity to grow, innovate, and share your insights. If you are proactive and passionate about advocating for patient needs, we encourage you to explore this opportunity further.
