Description
Validation Specialist - Warsaw
Validation Specialist - Poland
Validation Specialist with a major client in Warsaw
1. 5 years [or more] of experience working as a CSV consultant in controlled and validated environment/systems [Life Sciences/Pharma/Healthcare domain experience].
2. Well versed with FDA, EMA, ICH regulations, ER/ES requirements, GxP, GAMP, risk based approach
3. Good understanding of CSV concepts - Implementation cycle, Change Management process, Maintenance and Operations
4. Knowledge of validation methodologies of audit trail review process, data migration and system retirement activities
5. Good understanding and working experience to conduct risk assessments at various levels - System and Functional
6. Proactive in providing consultation on all validation topics [including deviation topics] to the project team and management, based on know-how of FDA/EMA regulations and company specific SOP's, directives and policies. Make sure the team is following applicable procedures
7. Excellent Communications in both - written & verbal in ENGLISH language. Strong analytical and problem-solving abilities
8. Well versed with tools like - HPALM, HPSM, Service Now, Microsoft Office suite
9. Passionate about adapting to new tools, technologies, and processes and encourage team members to adopt them in the working environment to increase the efficiency and effectiveness
10. Ability to work with virtual teams. Contributes to team effort by accomplishing related results as needed
Shortlisting immediately - interviews this week