Quality Assurance Manager
vor 4 Wochen
About the Role:
This is a challenging opportunity to join Biogen as a Quality Assurance Manager, where you will play a key role in ensuring the quality of our medicinal products. As the Deputy Responsible Person, you will be responsible for ensuring compliance with all national and international regulations, including GMP and GDP.
Key Responsibilities:
- Ensure quality assurance and compliance with all regulations, including GMP and GDP.
- Oversee quality systems and ensure that all Biogen and applicable GxP regulations are met.
- Manage quality records, including deviations, CAPAs, and change controls.
- Support audits and health authority inspections, including readiness and follow-up.
- Develop and maintain local quality agreements and procedures.
- Manage temperature excursion assessments and decide on the usability of affected products.
Requirements:
- Higher education in pharmaceutical or natural sciences, minimum Master's level, preferably PhD or Pharmacist.
- 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, and inspections.
- Fluent in English and German (speaking and writing).
- Good knowledge of Biogen procedural documents, International Guidelines, and regulations in GMP and GDP.
About Biogen:
Biogen is a global team with a commitment to excellence and a pioneering spirit. 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.
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