QUALITY ASSURANCE MANAGER / MUB
2012-10-17
Our client, biotechnology company developing new therapies is looking for Quality Assurance Professional
Qualification/background
Advanced (preferably) degree in healthcare related field (MD, PharmDr, Life Science), experience with quality assurance/GCP auditing in biopharmaceutical industry (including CA, CRO, BioPharma) in clinical development, GCP knowledge, certified auditor
Responsibility/key activities
QA system , GCP related audits (internal documents/systems/procedures, CROs, PV, Vendors, Sites), Audit´s reports and CAPA tracking, compliance with external regulation of QAin clinical development in Europe, USA, readiness for QA/GCP inspections, involvement with QA/GCP inspections, liasing with external parties , QA auditing vendor management, QA risk assessment and risk minimisation, QA training and education, QA budget
Skills/knowledge/competencies
Working knowledge of Czech and international (EU,US) product safety/PV regulatory environment, fluent English, ability and willingness to learn, willingness to travel, communication skills
Region: Czech Republic, Europe, USA
In case of interest please send your CV to Marcela Bukačová at bukacova@hays.cz
