Quality Assurance Deputy
vor 1 Woche
About the Role:
We are seeking a highly skilled Quality Assurance Deputy to join our team at Biogen Switzerland AG. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and integrity of our medicinal products.
Responsibilities:
- Act as the Deputy of the Responsible Person (RP) / Fachtechnisch verantwortliche Person (FvP) according to the Swiss Medicinal Products Licensing Ordinance (MPLO), SR , Arts., 12, 13, 17, 18 and the Swissmedic Technical Interpretation I-SMI.TI.17.
- Oversee quality assurance and support GxP activities at Biogen Affiliates and Distribution partners to ensure product quality all the way to patient.
- Ensure control of the distribution chain to maintain quality and integrity of medicinal products, new product launches and product related issues in cooperation with the different functional areas.
- Develop and maintain local Quality Agreements.
- Ensure that any additional requirements imposed on certain products by local Regulatory Bodies are adhered to.
- Develop and maintain local procedures in alignment with the local regulations and Global QMS.
Requirements:
- Higher education in pharmaceutical or natural sciences. Minimum of Master Level, preferably PhD or Pharmacist.
- Swissmedic Technical Interpretation I-SMI.TI.17
- At least 5 years' experience in pharmaceutical or related industry in the field of QA/RA.
- Track record in the field of QA including registrations, audits & inspections.
- Fluent in English and German (speaking & writing).
- Willingness to continuously learn.
- Good knowledge of Biogen procedural documents, International Guidelines such as ICH/GCP etc.
- Good understanding of regulations in GMP and GDP, good knowledge of certification processes
About Biogen:
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission.
Why Join Us:
We offer a dynamic and inclusive work environment, where every employee feels empowered and inspired to learn more about our DE&I efforts. We are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. Join our team and be part of a global movement that is changing lives through innovative medicines and pioneering research.
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