BERGENBIO Salary
MAGDALEN CENTRE OXFORD SCIENCE PARK OXFORD OX4 4GA UNITED KINGDOM
TIN: 10555293
BERGENBIO Premium profile inactive Premium profile inactive
Earnings on positions in BERGENBIO
BERGENBIO is looking for employees for positions:
quality assurance manager
Working hours
- full-time
Responsibility
- participating & supporting inspections to ensure inspection readiness
- collating KPIs and matrices and addressing any shortfalls
- support vendor selection and supplier qualification
- development, improvement, and maintenance of our Quality Management System including periodic review & revision of SOP’s, ensuring training compliance, managing GxP change control procedures, deviations & investigations, and conducting internal audits and trend analysis and admin support
- oversee GxP activities for vendors/suppliers including audit schedule implementation, oversight of vendor deviations, non-conformances, complaints & investigations, and verification of implementation & effectiveness of CAPA plans & deviations
Requirements
- bachelor’s degree in a life science subject
- experience managing GCP compliance activities
- understanding and experience of International ICH-GCP and clinical quality laws, regulations and guidelines
- experience providing internal consultation and training on quality systems and GCP
- previous exposure to GMP would be an advantage
- experience of regulatory inspections and GCP auditing beneficial