Qualified Person

• Own, review and approve SOP’s and other GDP/GMP documentation and records
• 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
• 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
• Provide QP support to the site during audits and regulatory inspections to determine effectiveness, and compliance with applicable standards and regulations
• 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
• Provides support during regulatory inspections or customer audits as requested by the company, before, during and/or after the event

• University Degree in Pharmacy
• 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

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards