TRANSCENTA HOLDING - A global Fully Integrated Biotherapeutics Company
Transcenta, biologics, antibody
1. Perform/coordinate GCP related audits of investigator sites, vendors, regulatory documents.
2. Coordinate/perform internal quality system audits applied to clinical development activities.
3. Verify the compliance with the applicable regulatory requirements and guidelines concerning the Quality
4. Ensures appropriate and timely escalation of quality issues, to the line manager.
5. Provides inspection management support as appropriate.
6. Maintain a Database for vendors and investigational sites audits.
7. Acts as a strong technical resource to resolve GCP issues based on knowledge of relevant SOPs, GCP, applicable local regulations & guidelines.
1. Broad knowledge of the drug development process, GCP guidelines, and applicable regulations.
2. Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective.
3. Familiarity with existing company systems, policies and procedures and knowledge of multiple therapeutic areas and nonclinical study conduct is desirable.
4. Able to work independently
5. Able to communicate the audit findings to stakeholders in both verbal and written formats.
6. Strong interpersonal skills with the ability to work effectively in teams.
7. Able to work for multi-task and manage time efficiently and effectively.
8. Able to work in a culturally diverse environment.
9. Education/Experience: BS/BA degree in relevant area with experience in clinical operation, project management field and experience in the pharmaceutical industry including experience of audits is preferable