Role DescriptionAs QA Specialist Validation you will report to the Senior Manager QA. The Amgen Breda technical QA team consists of 5 members and is part of the Breda QA organization of 45 people. The Breda technical QA group keeps oversight on introduction and modification of equipment, information systems and packaging configurations for commercial secondary packaging operations. By controlling the critical aspect of our operations and systems throughout the life cycle, we safeguard the high quality of our medicines. Additionally, we provide quality engineering support for quality investigations and testing strategies. As QA Specialist Validation you will be the liaison between quality and engineering to ensure new equipment is introduced within manufacturing conforming quality guidelines. You will work closely together in different project teams with the following departments: Process Development (PD), Maintenance and Engineering (M&E), Production, Information Systems (IS) located both in Breda and internationally.
Responsibilities- Agree on the validation strategy and provide guidance regarding design, characterization and validation for equipment and information systems in cooperation with the other departments; - Assure agreed validation strategy is properly documented and aligned with procedural and regulatory requirements by reviewing and approving validation documentation; - Provide support to Plant QA regarding equipment or information system related production issues. You provide quality engineering support to establish appropriate sampling plans and acceptance criteria; - Project team member to develop efficient quality processes and translate them in standard operating procedures; - Perform final review of (technical) change controls, confirming assessments of different stakeholders are complete and all tasks are correctly represented in the record.
Requirements• Master degree related to the pharmaceutical industry; • At least 5 years of professional experience within a GMP environment; • Relevant experience with equipment and automation validation; • Knowledge of the Quality Assurance principles; • Able to work on a wide variety of projects simultaneously; • Able to work in a changing environment; • Fluent in English.
Other informationWe 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. 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.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ivo Huijskens.