We want to expand our team and we are looking for a Quality Assurance Manager - Timisoara, Romania
The Quality Assurance program includes the development of service standards and audits, continuous quality improvement and developing plans to meet quality assurance objectives.
The Quality Assurance Manager provides reports on quality assurance and program evaluation for the organization.
We are looking for someone who demonstrates:
- Intense collaboration
- Passionate customer focus
- Tenacious commitment to continuous improvement
- Relentless drive to win
Here is a glimpse of what you will do:
Ensure the periodic revision of the SOPs and the relative training of the staff.
Ensure clinical trial quality checks, periodically audit clinical trials operations and management, making the audit plan, audit implementation and issue audit report.
Review and tracking the audit report.
Audit support functions processes and documentation based on yearly internal audit plan.
Coordinate related departments to make CAPA (Corrective Actions and Preventive Actions) response and track CAPA implementation according to clients’ audit observations or internal audit observations.
Evaluate the appropriateness of the general training activity of the personnel and of that performed for each individual clinical trial.
Support the annual training plan.
Handle internal and external quality aspects.
Periodicaly reporting to management.
Bachelor degree or above in Medical, Pharmacology or Biology related major
Advanced knowledge of the English language. Other languages represent an advantage
Adequate knowledge of new drug development, clinical operation, local regulation, GCP
2-3 years QA working experience, QA or audit working experience in global company is preferred
Strong planning, coordination, and time management skills to effectively support regularly scheduled and targeted audit, program evaluation and service planning
Continuous business experience of at least 1 year or which at least 1 in the field of quality management
Good working and proactive attitude
Value importance of teamwork
What we offer:
Dynamic working environment in a growing international company
Opportunity for professional development
A culture of mutual respect and an outstanding working environment
We would be interested in collaborating with you.
If you are interested, please do not hesitate to send your CV .