Amgen Specialist QA Complaints in Breda, Netherlands

About Amgen

Our Mission: To Serve Patients

Amgen is one of the world's leading biotechnology companies. Amgen is a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses.

Our belief-and the core of our strategy-is that innovative, highly differentiated medicines that provide large clinical benefits in addressing serious diseases are medicines that will not only help patients, but also will help reduce the social and economic burden of disease in society today.

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:

Specialist QA Complaints

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

Product Disposition

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 Product Complaints group at Amgen

Product complaints investigations are about improving our patient's experience with Amgen's products by providing timely, thorough, and patient focus investigations which identify and implement corrective and preventative actions that promote a culture of continuous improvement and quality.

The Product complaints group is part of the Quality organization. As Specialist QA, you will report into the Senior Manager QA. The Amgen Breda product complaints team consists of 8 people and is part of a broader complaint network counting over 45 staff. On a daily basis you will interact with the Amgen complaints network and with numerous stakeholders located both in Breda as internationally.

You have a quality background, both in Education (Pharmacist, biomedical, bio-engineering, biotechnology) and you have worked for a few years in a pharmaceutical environment, ideally a manufacturing or operations plant. You are able to maintain oversight on different projects and dive into details when required. 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.

Job Responsibilities:

Provide guidance and support to the complaints team in regards to investigation of commercial complaints

Lead and manage product complaint investigations, product security investigations, safety quality investigations, trend investigations and consolidated investigations for Amgen commercial products

Partner with corporate product quality surveillance, assessors from other Amgen sites and contracted supplier/manufacturers to resolve product complaints investigations

Act as Amgen Breda site representative in the Amgen product complaint networkAttend Network meetings and provide meaningful input and expertise

Support Network activities and continuous improvement initiatives

Perform data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner

Follow-up on corrective actions derived from investigations through completion

Review and approve complaints related NC and CAPA

Write, review and approve procedures and/or job aids in compliance with corporate, site and regulatory requirements

Liaise with Operations, Warehouse, Packaging Development and Engineering to provide information on complaints for process improvement initiatives

Train Amgen Breda and Amgen affiliate staff in complaint handling procedures

Act as impact assessor in projects/change controls

Support audits (internal and third party) and Regulatory Inspections by presenting the Amgen product complaint system and records and follow-up on commitments


Must haves:

Master's degree (e.g. in Pharmacy, Industrial Pharmacy, Bio-engineering,... ) and 3+ years of experience in pharmaceutical industry

Fluent in English

Sound knowledge of Quality Assurance principles, Good Manufacturing Practices and Good Distribution Practices

Computer literacy

Nice to haves:

Experience in Quality Assurance, including handling product complaints investigations

Track record of success in international working environment

Experience leading cross functional teams

Experience leading investigation in Operations (Root Cause Analysis)

Required Competencies:

Problem solving

Decision Making

Excellent written and verbal communication skills, including facilitation and presentation skills

Autonomous and self-motivated

Team player, able to work effectively with various levels and departmental groups

Influencing skills

Ability to handle multiple projects simultaneously

Attention to details

Ability to prioritize and meet deadlines

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.

Please note:

An online assessment is part of the recruitment process.

For this position we only consider candidates who live in the Netherlands or on a commuting distance from our Breda office, no relocation fee is offered for the position.