Quality Assurance Specialist II - GCP
Core
Standardize and harmonize the quality management system for clinical studies in cosmetics and hygiene, ensuring compliance with GCP and regulatory standards while overseeing study execution and audits.
Role type
Senior IC Quality Assurance Specialist (Clinical Trials)
Builds
Clinical trial studies for human subjects in cosmetics and hygiene
Domain
Life Sciences / Clinical Research / Quality Assurance
Deliverable
client delivery
Required skills
GCP compliance, ISO 19011 auditing, regulatory standards knowledge (FDA, ICH), clinical study monitoring, KPI implementation, cross-functional collaboration
Preferred skills
GDP, GLP, ICH E6 standards, lead auditor experience, clinical monitoring experience
Technologies
ISO 19011, FDA systems, ICH frameworks
Responsibilities
Perform internal audits according to ISO 19011 standards, oversee clinical studies at Union Site, conduct real-time reviews of clinical documentation, liaise with operational leaders on quality manual updates, ensure study completion timelines via KPI monitoring, create cross-training course lists for QA teams
Seniority
Senior, hands-on IC
