QA Engineer Specialist
Core
Provide Quality Assurance guidance and ensure compliance with cGMP regulations for change-controlled projects in plasma-derived product manufacturing.
Role type
Quality Engineer / QA Specialist (GMP)
Builds
GMP-regulated production processes and systems for plasma-derived medicines
Domain
Life Sciences / Biotechnology / Pharmaceutical Manufacturing
Deliverable
client delivery
Required skills
cGMP regulations, Change Control, Validation & Qualification, QMS principles, risk assessment, stakeholder management, regulatory inspections, CAPA management
Preferred skills
Dutch language proficiency
Technologies
Change Control systems, QMS systems
Responsibilities
Ensure compliance with internal policies and external regulatory requirements during change implementation; Act as SME for Change Control and QA processes; Assess quality impact and regulatory compliance of proposed changes; Identify risks and define mitigation actions; Support change owners with implementation planning; Approve and release systems for GMP use; Act as SME during audits and inspections; Own and manage CAPAs related to Change Control
Seniority
Mid-level, hands-on IC