Quality assurance manager
Tasks:
- Development and implementation of the Clinical Operation Plans, Logs, update and create SOPs for the quality relevant processes in accordance with the local legislation requirements, international quality requirements ICH-GCP.
- Preparation/reconciliation/approval of the training materials and presentations, control of timely trainings performance on the ICH-GCP and SOPs. Develop and implement the procedures according to the QA requirement and standards for Clinical Operation department.
- Quality Improvement Plans/management reviews preparation.
- Leading external and internal audits of the company’s QM reports drafting/reconcilication/signatures collection.
- CAPA implementation as a result of the audit monitoring.
- Change management of the clinical operations documentation and SOPs.
- Leading the (potential) suppliers/partners/distributors assessment/maintenance process including audits performance, reports compilation, CAPA implementation monitoring, development and signing of the QAAs; Quality Assessment of the third part vendors.
- Timely reporting.
- To be guided by the corporate Compliance and Ethical principles.
- To populate the Quality Management System with reports, records, audits and procedural documentation relating to the performance and operations Sections.
Requirements:
- More than 10 years experiences in the clinical research industry.
- Medical or biological background would be highly appreciated!
- English (both written and verbal) at advanced+ level.