Quality Assurance Specialist
Core
Maintain and improve the Quality Management System (QMS) to ensure compliance with GDP, GMP, and local regulations for pharmaceutical products in Nordic markets.
Role type
Quality Assurance Specialist (Pharmaceuticals)
Builds
Compliance with regulatory standards and internal quality objectives for consumer health products
Domain
Pharmaceuticals / Life Sciences / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management System (QMS) knowledge, GDP/GMP compliance, complaint handling, Product Quality Review (PQR) coordination, CAPA implementation, risk management, audit participation, supplier oversight
Preferred skills
Experience in GDP/GMP environments, knowledge of pharmaceutical regulations, exposure to internal/external audits, familiarity with warehousing/distribution operations
Technologies
QMS platforms, regulatory databases
Responsibilities
Support product release activities and Quality Operations; manage complaint handling processes; support Product Quality Review (PQR) processes; act as SME for QMS processes; ensure compliance with GDP/GMP; partner with cross-functional stakeholders; oversee third-party service providers; contribute to Management Review activities; support quality risk management; participate in audits and inspection readiness; drive CAPA implementation.
Seniority
Junior to Mid-level, hands-on IC