Specialist QA/QP- Product Lifecycle Management

Amgen is a value-based organization with a powerful sense of shared purpose toward our mission: to serve patients. At Amgen Breda, The Netherlands, medicines are labeled, assembled, stored, and shipped to various countries worldwide. Every day, more than 1000 people from 42 different nationalities work on supply chain processes, manufacturing, marketing, sales of our medicines, and clinical research into new treatments.

We are currently looking for a Specialist Quality Assurance/Qualified Person - Product Lifecycle Management

LIVE

What You Will Do

In this role, you have the opportunity to be a key contributor during product launches and product lifecycle management activities.

You will ensure that variations are seamlessly integrated into operations, adhering to Amgen's procedures, policies, and regulatory requirements. Additionally, you will set up Quality processes on time, so new products can be received, processed, released, and shipped to the market.

Your responsibilities will also include QP activities such as batch release and reportability assessments.

If you are looking to gain a broad understanding of Amgen's processes, to qualify as a Qualified Person, and to collaborate with a diverse range of stakeholders --> take your career to the next level and apply today !

In this vital role, you will:

• Release product (Finished Drug Product & Inspected Drug Product) for various markets, ensuring compliance with regulatory and quality standards.
• Act as QA contact for all activities related to new product introductions and product life cycle management including, but not limited to, change control assessment, review, and approval.
• Provide guidance and direction to Quality, Production, Warehouse/ Distribution, and Supply Chain staff in regard to compliance with quality policies, standards, and procedures.
• Assess and approve deviations, CAPAs, and change controls, taking ownership when required.
• Lead and participate in internal and external audits and inspections as needed.
• Own, review, and approve quality-related documentation (e.g. SOPs, Training, Risk Assessments).
• Participate in global Quality initiatives ensuring that input from Amgen Breda is provided and lead implementation activities on our site.
• Monitor the regulatory landscape and ensure that Amgen's quality management system complies with new regulations
• Participate/lead in continuous improvement efforts and projects including (new) product launch teams.
• Review and sign QP declarations and other documents supporting filing activities.
• Review and sign Quality Agreements.

WIN

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek is an effective communicator with these qualifications:

• Master’s in science in Pharmacy or Lifesciences ( mandatory ).
• Knowledgeable and skilled to fulfill the requirements of EU directive 2001/83/EC article 49 (Qualified Person ).
• Experience in Quality Assurance within the pharmaceutical, biotechnology, or medical devices industry.
• Strong knowledge of Good Manufacturing Practices ( GMP ) and Good Distribution Practices ( GDP ).
• Demonstrated ability to make risk-based decisions and solve problems scientifically.
• Acquired practical experience in Good Manufacturing Practice ( GMP ) over at least 2 years .
• Proficiency in written and verbal communication, including technical writing and collaboration with cross-functional teams.

THRIVE

What You Can Expect Of Us

As we work to develop treatments that take care of others, we are equally dedicated to the well-being and development of our team members. Amgen is regularly recognized as a Great Place To Work.

• Vast opportunities to learn and grow within our global organization.
• A diverse and inclusive environment where innovation is encouraged.
• A competitive Total Rewards Plan, including a salary, bonus structure, 13th month, holiday allowance, and collective health insurance.
• Focus on vitality with an on-site gym, a wellness program, and healthy food options.