Quality Assurance Specialist (m/w/d)
Core
Execute projects for clients in the Pharma and Life-Science industry, ensuring compliance with GMP regulations through document creation, review, and validation.
Role type
Quality Assurance Specialist (Pharma/Life-Science)
Builds
Manufacturing and testing protocols, validation documents, SOPs, risk analyses, and qualification documents for pharmaceutical clients.
Domain
Pharmaceutical industry / Life-Science / GxP Compliance
Required skills
GMP compliance, CAPA management, change control, batch record review, risk analysis, SOP development, audit preparation
Preferred skills
Project management, stakeholder communication, process optimization
Technologies
GxP regulatory frameworks (EU/US)
Responsibilities
Create, review, and approve manufacturing and testing protocols; Develop and update SOPs; Manage changes and deviations (CAPA, change control); Conduct risk analyses and qualification documents; Participate in internal and external GMP audits.
Seniority
Mid-level, hands-on specialist
