Qualified Person

OverviewJoin Amgen's Mission of Serving Patients.At Amgen, if you feel like you're part of something bigger, it's because you are.Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since ****, we've helped pioneer biotechnology in our fight against the world's toughest diseases.With our focus on four therapeutic areas – Oncology, Inflammation, General Medicine, and Rare Disease – we reach millions of patients each year.As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.Our award-winning culture is collaborative, innovative, and science based.If you have a passion for challenges and the opportunities that lie within them, you'll thrive as part of the Amgen team.Join us and transform the lives of patients while transforming your career.Qualified PersonWhat you will doLet's do this.Let's change the world.In this QP role you will own, review and approve SOPs and other GDP/GMP documentation and records, ensuring that Corporate, Site and Regulatory requirements are met.Ensure that each batch of medicinal product is manufactured and checked in compliance with EU Good Manufacturing Practice (GMP), the product's marketing authorization (MA), and relevant legal requirements, prior to its release.Perform review and approval of validation documentation.Lead and participate in internal and external audits as needed.Maintain a close contact and familiarity with Amgen Quality systems and programs utilized at other Amgen sites.Provide guidance and direction to Quality, Production, Warehouse/Distribution and Supply Chain staff regarding compliance with quality policies, standards and procedures.Evaluate and assess change control records, non-conformances and CAPAs.Participate in global Quality initiatives as a site subject matter expert.Participate or lead projects and improvement efforts including product launches.Support the evaluation of quality and distribution complaints.Support regulatory inspections or various questions from regulatory bodies.Perform activities as required per Amgen procedures as QA staff, and in particular where the role of QP is specified in the procedures.Execute audit strategy and lead process audits.Provide support during regulatory inspections or customer audits as requested by the company, before, during and/or after the event.Work on complex problems involving analysis of situations or data from various sources; interpret GMP regulations to resolve problems and in the design of systems, processes or procedures.Ability to effectively plan, organize, and execute work to ensure deliverables are consistently met.What we expect of youWe are all different, yet we all use our unique contributions to serve patients.Basic QualificationsUniversity Degree in Pharmacy or University Degree in a Science related discipline with a post graduate course, which together with the primary qualification satisfies the educational requirements as defined in Directive *******/ECKnowledge of the processes involved in manufacturing (GMP), warehousing, supply chain, equipment engineering principles and validation.Knowledge of applicable regulatory requirementsWhat you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being.From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.Apply now and make a lasting impact with the Amgen team.careers.amgen.comAs 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 and live the Amgen values to continue advancing science to serve patients.Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.Please contact us to request accommodation.#J-*****-Ljbffr