General Information

Job Advert Title
QA Officer
Location
Netherlands
Function/Business Area
Quality
Department
Compliance
Employment Class
Permanent

Description

QA Officer Compliance


About Astellas:


At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.


Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society. Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.


Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.


We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership. Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.


About This Job:


The manufacturing site in Meppel is a facility with a high-quality standard.

We are recruiting a new member who works with us to maintain and further improve the quality standard and contribute to bringing our products to patients all over the world.


Core tasks/activities:


  • In the role of process owner, overseeing the correct use of the Vault Quality documentation system in Meppel and thereby ensuring a consistently high standard of documentation.
  • Making improvement proposals for Vault Quality in cooperation with other EU plants.
  • Executing activities in the area of Record Information Management and Data Integrity for GMP documentation.
  • Collecting data for and writing Product Quality Reviews
  • Contributing to the proper functioning of the Pharmaceutical Quality System
  • Supporting other departments in increasing GMP compliance
  • Performing self-inspections
  • Coordinating the implementation of new GMP guidelines and Global SOPs within Meppel
  • Maintaining the Site Master File
  • Completing questionnaires from authorities in various countries for the renewal of the GMP certificate.
  • Participating in or leading improvement projects, both within Meppel and in collaboration with other Astellas entities.

Essential Knowledge & Experience:


  • Completed HBO/WO education in an analytical-chemical/physical/life sciences field
  • Several years of relevant experience in a GMP environment
  • Excellent computer skills
  • A good understanding of the business processes of Astellas Meppel
  • Good analytical skills with regard to data review and trend analyses
  • Continuous improvement mindset and shaping innovations
  • Good communication and organizational skills
  • Excellent command of Dutch and English in word and writing
  • Determined, tenacious, accurate and flexible.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.