QA-Associate (GDP Responsible Person)応募 後で応募 求人ID R0011674 掲載日 08/27/2019 Location:Hoofddorp, Netherlands
Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as Quality Associate (GDP Responsible Person) at our Dutch office in Hoofddorp.
Takeda is a global pharmaceutical company with more than 50,000 professionals working together across more than 70 countries. We have an unwavering dedication to put people first and we live our values of Takeda-ism: Integrity, Fairness, Honesty, and Perseverance. We are united by our more than 230-year legacy of research-based pharmaceuticals and our mission to strive toward Better Health and a Brighter Future for people worldwide through leading innovation in medicine.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.
A Typical Day as Quality Associate focuses on carrying out the role of Responsible Person for Takeda Nederland with regard to Good Distribution Practice (GDP). The major responsibilities are:
- maintaining a Quality Management System according to GDP Guidelines
- ensuring relevant customer quality complaints are dealt with effectively
- ensuring suppliers and customers are approved, including due diligence checks
- ensuring self-inspections are being performed
- deciding on the final disposition of returned, rejected, recalled or falsified products
- coordinating any recall operations for Takeda's medicinal products
- acting as the contact person for the Dutch Healthcare Authorities
This function reports to the Medical Director with a dotted line to the General Manager and the Regional Head of Commercial Quality.
For education and experience the following is required:
- University degree (MSc) in pharmacy, pharmaceutical chemistry and technology or similar
- GDP training courses, demonstrable by certificate(s)
- At least 2 years of practical experience in storage and distribution activities of medicinal products, preferably with cold chain management and transport validation
- Experience in a similar position at a local affiliate in the pharmaceutical industry is an advantage