Sr. Associate QA

3 weken geleden

Breda, Noord-Brabant, Nederland Progressive Recruitment Voltijd

We have a current opportunity for a Sr. Associate QA clinical supply chain at one of our biotechnology clients in Breda.

At Amgen Breda (ABR), The Netherlands, medicines are labelled, assembled, stored and eventually shipped to various countries worldwide. Every day more than 1000 people with 38 different nationalities are working on supply chain processes, manufacturing, marketing and sales of our medicines and clinical research into new medicines.

What will you do

As a Sr. Associate QA clinical supply chain, you will be responsible for providing QA oversight on the supply chain of clinical trial products and provide support in the clinical production area. In this role, you will provide QA support for clinical products received and distributed from ABR to clinical sites and depots. You will be in direct contact with a wide range of stakeholders, and be responsible for establishing effective working relationships with key stakeholders including Global Clinical Supply Chain (GCSCM), Warehouse/Distribution, Production, Site Quality, Clinical Research Management, and Regulatory Affairs.

What are your responsibilities?

In this role you act as a Sr. Associate QA, you are mainly responsible to provide quality guidance for Investigational Medicinal Products assuring that GDP and GMP standards are maintained, and to support Clinical QA primary processes:

  • Responsible for batch review to support QP batch certification of Investigational Medicinal Product in compliance with EU and international regulations
  • Compliance review and approval of clinical label artwork
  • Responsible for assessment of temperature excursions during transport and at clinical sites
  • Assist in resolution of compliance and quality issues related to the manufacturing and transport of clinical products
  • Review and approve minor deviations ensuring all procedural requirements are met
  • Owning and generating operational SOP's and Work Instructions
  • Review of SOP's ensuring that Corporate, Site and Regulatory requirements are met
  • Responsible for preparation of monthly metrics
  • Identify issues and work cross functionally to ensure a solution
  • Support Clinical Packaging and Labelling Operations as Quality on the floor: support with pack checks, batch record review and issue handling during manufacturing. Execute QA compliance checks.

What do you need to be successful in this role?

  • Preferably a Master in Science degree in Life Sciences or related field.
  • Typically 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review, investigations and analytical testing
  • Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/or Good Clinical Practice (GCP) knowledge
  • Fluent in English.

Why join?

This is a Fortune 150 company and one of the world's leading biotechnology companies operating in nearly 100 countries around the world. We are a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses.

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