Amgen Specialist Quality Assurance (Qualified Person) in Breda, Netherlands
Amgen is a values-based organization with a powerful sense of shared purpose toward our mission: to serve patients. We provide the capabilities, resources, and rewards of a global enterprise, while maintaining the entrepreneurialism and pioneering spirit that marked our early days as a biotechnology innovator. We encourage our team members to have fulfilling and meaningful careers through challenging assignments, career development, and valuable opportunities such as this job opportunity.
Specialist Quality Assurance (Qualified Person)
Located in Breda, the Netherlands
Amgen Europe B.V.
Amgen Europe B.V. is based in the South of the Netherlands, in the beautiful city of Breda and is part of Amgen's global manufacturing network, including eight manufacturing plants around the globe. The main Operations conducted at Amgen Breda are:
Production: Labeling, Assembly and Secondary Packaging of Amgen product
Distribution to 75+ countries worldwide
These activities are shared amongst several organizations such as Production, Supply Chain, Quality Assurance, Information Services, Finance, Marketing & Sales and HR. With approximately 600 employees, the entire site of Amgen Breda works towards one common goal: to serve 'every patient, every time'.
The QA Product Lifecycle Management & Product QP team at Amgen Breda
The QA Product Lifecycle Management & Product QP team is providing QA oversight during the implementation of new products, but also during implementation of CMC and labeling variations of existing products. They make sure that the change control records, associated with those product launches and variations, are implemented in a controlled manner. Moreover, they act as Qualified Person, releasing unlabeled vials/syringes for the EU market, managing quality agreements, signing QP declarations, performing internal audits, etc.
The Product Quality & Compliance group is part of the Amgen Breda Quality organization. As Specialist QA/QP, you will report into the Senior Manager QA/Head QP - The Amgen Breda product Quality & Compliance team consists of 3 people. On a daily basis you will interact with numerous stakeholders located both in Breda as 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 (Finished Drug Product & Inspected Drug Product)
Act as QA contact for all activities related to new product introductions and product life cycle management, including but not limited to change control review and approval.
Provide guidance and direction to Quality, Production, Warehouse/ Distribution and Supply Chain staff in regards to compliance with quality policies, standards and procedures
Act as QA contact for Non-conformances and CAPA's.
Lead and participate in ABR internal and external audits as needed
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 in Science degree (e.g. in Pharmacy, Bio-engineering,... ) and 3+ years of experience in pharmaceutical industry
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)
Fluent in English
Nice to haves:
Experience as QP
Track record of success in international working environment
Experience working in cross functional teams
Amgen is 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 our 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.