Overview
QA Engineer Specialist Jobs in Amsterdam Area at Hays
Title: QA Engineer Specialist
Company: Hays
Location: Amsterdam Area
Your new company
Our client is a leading organisation dedicated to providing high‑quality plasma‑derived products that transform lives worldwide. Through highly complex and advanced processes, proteins are isolated from blood plasma and developed into life‑saving medicines. Beyond patient care, the organisation is committed to delivering innovative solutions for client partners. Their colleagues go the extra mile every day to ensure the highest standards of quality, safety, and patient impact.
Your new role:
As a Quality Engineer / QA Specialist, you will provide Quality Assurance guidance and actively participate in change‑controlled projects impacting GMP‑regulated business processes. You will play a critical role in ensuring that documentation, systems, processes, and reports fully comply with cGMP regulations, internal quality policies, and external regulatory requirements.
In your new position, you will:
- Ensure compliance with internal policies, cGMP regulations, and external requirements during and after change implementation
- Act as a Subject-Matter Expert (SME) for Change Control and Quality Assurance processes
- Participate as an independent QA representative in multidisciplinary and global project teams
- Assess the quality impact and regulatory compliance of proposed changes to production processes
- Identify quality, compliance, patient, and business risks and define effective mitigation actions
- Support change owners with implementation planning, timelines, and issue resolution
- Ensure accurate and consistent translation of strategies into Change Control documentation and systems
- Monitor Change Control performance and proactively escalate risks when necessary.
- Approve and release systems and processes for GMP use
- Provide training, coaching, and quality guidance across the organisation
- Act as an SME during audits, inspections, and regulatory interactions
- Own and manage CAPAs related to Change Control activities.
- Represent QA in internal and external committees and stakeholder meetings.
What you'll need to succeed
- Bachelor’s or Master’s degree in Life Sciences, Engineering, Pharmacy, or a related discipline
- Several years of experience in Quality Assurance within a GMP‑regulated environment (pharmaceutical, biotech, or similar)
- Strong knowledge of Change Control, Validation & Qualification, and QMS principles
- Hands‑on experience with cGMP regulations and regulatory inspections
- Proven ability to assess risk, manage stakeholders, and support complex projects
- Excellent documentation, communication, and problem‑solving skills
- Fluency in English; Dutch is an advantage.
What you'll get in return:
Hays Detachering | This is a project that is ongoing until the end of the year. Extension of this project is unknown as of now, therefore, it cannot be guaranteed. With this contract, you will also receive a competitive salary and your travel expenses will be covered.
What you need to do now
If you are interested in this role as Quality Engineer, click ‘Apply now’ to send an up-to-date CV, or give us a call! Is this job isn’t quite right for you, but are you still looking for a new position? Please contact us for a confidential discussion on your career.
