Amgen Specialist QA Complaints in Breda, Netherlands
If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us as:
Specialist QA Complaints
At Amgen Breda 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 you will do
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.
We are seeking a Specialist Quality Complaints and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns and executes the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current, emerging internal and external requirements. In addition, the team translates information from the market to drive continuous improvement.
The Specialist facilitates cross-functional teams to conduct complex complaint investigations, determines corrective actions with their effectiveness and determines the steps necessary to ensure the proper level of control for product in distribution. You will align complaint closure requirements in adherence with pre-determined process step metrics to ensure timely closure of records.
Other responsibilities will include:
Ensuring quality of complaint records;
Execution of regulatory and SOP requirements;
Ensuring representation of ABR in Amgen Complaints Network by providing meaningful input and support implementation of the Network continuous improvement initiatives at ABR;
Partnering with assessors from other Amgen sites and contracted supplier/ manufacturers to resolve product complaints investigations;
Liaising with Operations, Warehouse, Packaging Development and Engineering to provide information on complaints for process improvement initiatives;
Supporting audits (internal and third party) and Regulatory Inspections by presenting the Amgen product complaint system and records and follow-up on commitments.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The problem solving professional we seek is a decision maker with these qualifications:
Master’s degree (e.g. in Pharmacy, Industrial Pharmacy, Bio-Engineering, etc.) and 3+ years of experience in pharmaceutical industry;
Sound knowledge of Quality Assurance principles, Good Manufacturing Practices and Good Distribution Practices;
Experience in Quality Assurance, including handling product complaints investigations;
Track record of success in international working environment;
Experience leading investigation in Operations (Root Cause Analysis);
Excellent written and verbal communication skills in English;
Autonomous and self-motivated;
Ability to maintain oversight in different projects and dive into details when required;
Team player, able to work effectively with various levels and departmental groups.
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization.
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
Generous Total Rewards Plan comprising competitive salary, bonus structure, fixed 13th month, holiday allowance and a collective health insurance.
Focus on vitality with an on-site gym, vitality program and a restaurant with healthy food.
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.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.