Specialist Plant QA/QP
Netherlands – Breda
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.
At Amgen Breda (ABR) medicines are labelled, assembled, stored and eventually shipped to various countries worldwide. Amgen Breda receives its products as semi-manufactured goods, which are then packed country-specific, stored and eventually shipped to various countries worldwide.
Every day more than 600 people in the Netherlands are working on supply chain processes, Engineering, marketing and sales of our medicines and clinical research into new medicines.
We encourage our team members to have fulfilling and meaningful careers through challenging assignments, career development, and valuable opportunities such as this:
Specialist Plant QA/QP
What are your responsibilities?
In this role you act as a Qualified person, you are responsible for releasing finished drug product lots while ensuring compliance with the requirements of the marketing authorization and good manufacturing practices. As a Specialist Plant QA, you provide guidance and direction to Production, Maintenance & Engineering and Quality staff regarding compliance with quality standards and procedures.
- You partner with production staff in performing risk analysis and the establishment of quality limits and requirements
- You own, review and approve production and plant QA related documents (e.g. SOPs, Forms, Training)
- You review and approve deviations and CAPA, initiate and own as needed.
- You perform impact assessment as part of change controls impacting production or QA processes
- You review and approve production equipment maintenance work orders
- You review and approve test protocols before use in production
- You perform GMP compliance checks in production
- You participate in internal audits and lead as appropriate
- Participate in regulatory inspections and partner audits
- You assist in development and delivery of GMP training for QA and production staff
- You lead and participate in Plant QA related projects/global QA initiatives as needed
- You lead and assist in various investigations as needed
- You assist in validation activities as needed including review and approval of validation documents
What do you need to be successful in this role?
- Master’s in science in Pharmacy or equivalent
- Thorough knowledge of the processes involved in clinical and commercial manufacturing (GMP), warehousing, supply chain, equipment engineering principles and validation
- Knowledgeable and skilled to fulfill the requirements of EU directive 2001/83/EC article 49 (Qualified Person).
- Acquired practical experience in Good Manufacturing Practice (GMP)
Why join Amgen?
Amgen 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.
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, we provide you with valuable opportunities to broaden your experience and maximize your potential in a modern working environment.
We encourage open dialogue and professional debate, and we collaborate 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.
The recruitment process
The high-level recruitment process is as follows: resume screening, first phone screening, assessment invitation, face to face interviews.
Due to our relocation policy we can only consider candidates who reside in the Netherlands or live within a commuting distance from Amgen Breda for this vacancy.
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