Quality Assurance Officer
Core
Ensuring quality within laboratory and operational processes, managing deviations, audits, and compliance with GxP/ISO standards.
Role type
Quality Assurance Officer
Builds
Compliance with regulatory requirements and internal quality systems
Domain
Life sciences / Pharmaceutical testing
Deliverable
client delivery
Required skills
GMP quality system knowledge, regulatory requirements knowledge (Eudralex, ICH), deviation management, change control, audit execution, documentation control, training delivery
Preferred skills
Microbiological QC testing knowledge, Dutch language proficiency, English language proficiency
Technologies
Electronic documentation systems
Responsibilities
Manage and assess deviations, changes, complaints, OOS, and CAPA; Maintain change control and deviation systems; Conduct internal audits and support external inspections; Train personnel on GMP and quality procedures; Create and revise QA procedures and work instructions; Manage GMP documentation system and archive; Ensure GxP compliance of personnel, studies, facility, and equipment
Seniority
Mid-level IC