Qualified Person

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Qualified Person

What you will do

Lets do this. Lets change the 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 products 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 in regard to compliance with quality policies standards and procedures.

• Evaluates 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.

• Supports the evaluation of quality and distribution complaints.

• Supports 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.

• Compliance:

  • Provide QP support to the site during audits and regulatory inspections to determine effectiveness and compliance with applicable standards and regulations.

  • Displays critical thinking expertise with the ability to define and implement a strategic approach to audits and inspections based on compliance and business knowledge.

  • Provide cGMP guidance to other stakeholders such as Manufacturing Facilities and Engineering Quality Control Supply Chain and Validation.

  • Support Site Readiness Preparation for regulatory inspections as .

  • Execute audit strategy and lead process audits

  • Provides support during regulatory inspections or customer audits as requested by the company before during and/or after the event.

  • Works on complex problems in which analysis of situations or data requires in-depth evaluation of various factors from many sources. Is adept at interpreting GMP regulations in the resolution of problems and in the design of systems processes or procedures.

  • Ability to effectively plan organize and execute work that ensures deliverables are consistently met.

  What we expect of you

  We are all different yet we all use our unique contributions to serve patients.

  Basic Qualifications:

  • University Degree in Pharmacy

  • OR University Degree in a Science related discipline together with a post graduate course which together with the primary qualification satisfies the educational requirements as defined in Directive 2001/83/EC

  • Knowledge of the processes involved in manufacturing (GMP) warehousing supply chain equipment engineering principles and validation. Knowledge of applicable regulatory requirements

  What you can expect of us

  As 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 well 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.

  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 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.