Specialist Quality Assurance Clinical - Netherlands
Specialist Quality Assurance Clinical
The Clinical Quality group at Amgen Breda
The Clinical Quality team is maintaining Quality Assurance (QA) oversight for clinical products received and distributed from the Amgen Breda facility to ensure an adequate, effective and efficient use of the Amgen Quality system, programs and procedures. They ensure that the clinical product release is efficient, effective and meet target timeframes from both a compliance and business perspective.
Moreover, some members of the team act as a Qualified Person for releasing Investigational Medicinal product used in EU clinical studies, managing Quality Agreements and signing QP declarations, etc.
The Clinical Quality team is part of the ABR Quality organization. As Specialist QA, you will report to the Senior Manager QA – The Amgen Breda Clinical Quality team consists of 5 people. On a daily basis you will interact with Global Clinical Supply Chain Management and numerous other stakeholders located both in Breda and internationally.
Preferably, you have had your first experience as a QP or alternatively you have a few years of experience in Quality Assurance and have the qualifications to become a QP. You are able to maintain oversight on different projects, dive into details when required and provide Quality guidance to other functions. Working in teams and communicating effectively with all kind of stakeholders is crucial in this role.
We offer you a great opportunity to be part of our growing company, work on your own development whilst making sure our medicines find their way to the patients who need them.
Product Disposition (Investigational Medicinal Product)
Act as QA contact for all activities related to new clinical products introductions, including but not limited to change control review and approval
Provide guidance and direction to Quality, Clinical Supply Chain Management, Production and Warehouse/ Distribution with regards to compliance with quality policies, standards and procedures
Act as QA contact for Non-conformances and CAPA’s
Participate in audits (internal, external, corporate, etc.) and in the implementation of audit commitments
Maintain Quality oversight for clinical products being distributed from the Amgen Breda facility and Logistic Service Providers
Write, review and approve procedures and/or job aids in compliance with corporate, site and regulatory requirements
Participate in global Quality initiatives ensuring that ABR input is provided and leading ABR implementation activities
Participate (lead) in various ABR projects and improvement efforts including (new) product launch teams
Masters or Bachelor degree and 3+ years of experience in pharmaceutical industry
Strong knowledge of Good Manufacturing Practices
Fluent in English
Nice to haves:
Knowledgeable and skilled to fulfil the requirements of EU directive 2001/83/EC article 49 (Qualified Person) and GDP guidelines 2013/C 343/01 chapter 2.2 (Responsible Person)
Track record of success in international working environment
Experience in supply chain management
Experience working in cross functional teams
A Fortune 150 company operating in nearly 100 countries around the world, we invest in highly skilled, dedicated and collaborative individuals who are ready to contribute to our mission in meaningful ways and make a difference in the lives of our patients.
That’s why, as a member of the Amgen team, we provide you with valuable opportunities to broaden your experience and maximize your potential. We ensure our staff are equipped to excel today and tomorrow by leveraging state-of-the-art technologies and modern working environments, encouraging open dialogue and professional debate, and collaborating with world-class talent and institutions around the globe. We believe in rewarding those who do rewarding work and are committed to providing careers that can help turn the tide of serious, life-interrupting illnesses.
An online assessment is part of the recruitment process.
Due to our relocation policy, for this vacancy, we can only consider candidates who reside in the Netherlands or candidates who live on a commuting distance from Amgen Breda.