- deviation processing and CAPA implementation; - documentation preparation in accordance with cGMP
- Document review
- Manufacture of Natalizumab, Vedolizumab, and Guselkumab
- Team management
- Training new employees
- Participation in leadership meetings
- Preparation of medicinal products from Wharton's Jelly
- Updating manufacturing instructions and procedures (SOP) according to GMP
- Manufacturing cost analysis
- Management project - BioPlanta
- Risk analysis, corrective and preventive actions CAPA
- Documentation according to GMP
- Isolation and preparation of cord tissue
- Storage of mesenchymal stem cells for commercial clients
- Work in cleanroom spaces according to GMP
- Documentation for preparation's cord tissue
- Verification of documentation used in the process
- Maintenance of the database
- Training new employees
Teamwork
Organizational Skill
Microsoft Office
Task prioritization
Flexible
Clinical Trial Associate
Clinical Trial Associate
English Language in Clinical Trials
Good Clinical Practice standard ICH GCP E6
Clinical Trials Basic & Advanced with Workshop - Trial Documentation
Principles of Regulatory Affairs for medicinal products, veterinary products with elements of pharmacovigilance management & Documentation for medicinal and veterinary products