Quality Assurance Specialist (m/f/d)
Core
Maintain and improve the Quality Management System (QMS) in a regulated biotechnology environment, ensuring compliance and driving continuous quality improvements.
Role type
Quality Assurance Specialist (regulated industry)
Builds
Quality Management System (QMS) compliance and operational effectiveness
Domain
Biotechnology / Life Sciences / Regulated Manufacturing
Required skills
Quality Management Systems (QMS), CAPA management, deviation handling, audit support, document control, quality metrics analysis, supplier quality management, continuous improvement methodologies
Preferred skills
Internal auditor qualification, root cause analysis, ERP systems (IFS), electronic QMS (EtQ), training delivery
Technologies
ISO 9001, ISO 13485, eQMS, Microsoft Office, IFS, EtQ
Responsibilities
Maintain and improve the Quality Management System (QMS) in line with ISO 9001 and internal quality requirements; Take ownership of quality events including deviations, non-conformances, CAPAs and change controls; Support internal and external audits; Analyse quality metrics and trends to recommend practical changes; Partner with Operations, Quality Control, Supply Chain and Customer Service to embed quality into everyday ways of working.
Seniority
Mid-level, hands-on IC