The role
Our QA team in the Netherlands consists of around 50 dedicated professionals who collaborate closely to safeguard product quality and deliver reliable solutions for patients worldwide
As a Specialist QA / Qualified Person, you will have a key responsibility in ensuring that medicinal products released from our site comply with EU and international regulatory requirements.
You will work closely with cross-functional teams and contribute to a culture where quality, innovation, and digital transformation are central to how we operate.
Within this role, you will also have the opportunity to engage in initiatives that drive digital innovation and continuous improvement.
If you are looking to broaden your understanding of Amgen’s processes, collaborate with a wide network of stakeholders, and grow your career as a Qualified Person, this role offers an excellent opportunity.
Key responsibilities:
- Perform batch certification of medicinal product and investigational medicinal product in accordance with EU and international regulatory requirements.
- Partner with Production, Warehouse/ Distribution and Supply Chain teams to ensure compliance with quality policies, standards and procedures.
- Serve as the QA contact for Deviations and CAPA’s, ensuring appropriate investigation and resolution
- Write, review and approve procedures and job aids, ensuring alignment with corporate, site, and regulatory requirements.
- Contribute to and drive continuous improvement projects in cross-functional collaboration
- Review and sign QP declarations and regulatory documentation supporting product filings.
What we expect of you:
- Eligibility to act as a Qualified Person according to EU directive 2001/83/EC article 49
- Master’s degree in Pharmacy or Lifesciences such as Medicine, Veterinary Medicine, Chemistry, Pharmaceutical Chemistry and Technology, Biology)
- At least 2 years of practical experience in Good Manufacturing Practice (GMP)
- Ability to problem solve with a scientific and risk-based approach to decision-making
- Demonstrated proficiency in written and verbal communication skills, including technical writing and stakeholder engagement
Interested? Send your CV to Daria at d.finikova@panda-int.com or call +31202044502.