Amgen Specialist QA - Audits & Inspections and Complaints 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.
At Amgen Breda, The Netherlands, we focus on the packaging and distribution part of the drugs we have developed which are produced at our international sites. The packaging and distribution is supported by the Operations, Customer Service and Demand, Information Systems and Quality departments.
The site also supports a sales organization.
Process Development, Operations and Quality (POQ) are the core divisions of Amgen that make sure the drugs are delivered to our patients. Made up of seven functions and spread across seven sites, POQ's aspiration is simple: Supply every patient, every time!
As the Specialist QA Audits & Inspections and Complaints you ensure that Amgen Breda (ABR) maintains a strong regulatory reputation through robust inspectional and audit program. You also ensure that Amgen Breda demonstrates GDP/GMP compliance and meets public service obligations. Then you ensure compliance of Amgen Breda (ABR) Audits and Inspections processes and execution with Amgen Standards and Procedures. And you ensure representation of ABR in Amgen Audits and Inspections Network by providing meaningful input and support implementation of the Network continuous improvement initiatives at ABR.
Responsible to manage inspections by EMA, FDA and other reg authorities as applicable at ABR site. Ensure inspection readiness at all times.
Support other Amgen sites/affiliates during regulatory inspections (by personal attendance) as required.
Manages Amgen Partners and Corporate Quality audits at ABR site. Leads ABR site preparation activities, readiness and follow-up activities.
Develops, executes and oversees a robust internal audit program. Lead audits as applicable.
Keep informed of GMP/GDP and industry trends, requirements and practices, and communicates these to QA and other applicable areas. Take an active role in educating staff in compliance expectations.
Own, review and approve SOPs and other GMP/GDP documentation and records (e.g. Complaints, NCs and CAPAs), ensuring that Corporate, Site and Regulatory requirements are met.
Act as Amgen Breda site representative in the Amgen Audits and Inspections network.
Attend Network meetings and provide meaningful input and expertise.
Support Network activities and continuous improvement initiatives.
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.
Perform data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner.
Provide guidance and support to the complaints team in regards to investigation of commercial complaints.
Act as impact assessor in projects/change controls.
Master's degree and 3+ years of experience in pharmaceutical environment (GMP/GDP).
Relevant experience in dealing with Quality Systems such as Deviations, CAPA, Complaints, Internal and External Audits.
Relevant experience related to interaction with regulatory bodies, including but not limited to for example IGJ, EMA, FDA.
Sound knowledge of Quality Assurance principles, Good Manufacturing Practices and Good Distribution Practices.
Fluent in English.
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.