Qualified Person (QP) - 12 Month Fixed Term Contract
Dublin, County Dublin, Ireland
Join Amgen’s mission to serve patients living with serious illnesses. With a focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—Amgen pioneers innovative medicines that help millions of patients live longer, fuller, and happier lives.
What You Will Do
* 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 in regard to 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.
* Provide QP support to the site during audits and regulatory inspections to determine effectiveness, and compliance with applicable standards and regulations.
* Display 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 required.
* 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 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, 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.
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.
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