Sasha Dahuc Email & Phone Number

Ghent, Flemish Region, Belgium

- Implement ICH GCP and CGLP principles contributing to Clinical Trial Risk management implementation.- Support to the Operations Team and oversee issues being promptly reported to the client. Proposing or develop jointly CAPAs to the client and ensure adequate and on time follow up.- Adequate staff training and awareness of GCLP and data integrity requirements and clinical trial protocol related risks. Ensure training of personnel concerning QMS elements and applicable quality guidelines, IATA, HIPAA and local safety regulations.- Report, escalate and resolve incident and client complaints.- Managing client complaints and ensure on time and quality resolution.- Hosting Audits and respond to audit reports.

Argentina

- Project Management: followed up activities related to projects for meet deadlines.- Ensured a through review of API and Vaccine process and batch documentation, guaranteed standards and safety regulations were accomplished.- Deviations: Recognized, discussed and rose any quality and compliance risks.- Reviewed and updated Dossiers for compliance.- Edited or reviewed Annual Product Quality Review (APQR).- Assisted the RP with Recall process, included mock recalls.- Led self-inspection audits and assisted to external audits.- Executed the roll out of the quality system (QMS), ensuring it was established and maintained, including change control, deviations, risk assessments and CAPA Change controls - raise, log, review, follow up on completion, ensure completion dates were adhered to include effectiveness checks.

Argentina

- Coordinated and supervised the adherence to clinical studies.- Carried out selection, initiation, monitoring and closeout visits.- Monitored compliance with local regulation and GCP.- Managed study supplies, medication supplies and medication accountability.- Ensured patient safety and well-being of test subjects. - Submitted of clinical trial documents for review and approval by those ethics committees.

Argentina

- Worked closely with the Project Trial Manager for timely delivery of recurrent tasks- Project Trial Manager Back-up. - Interacted with Sponsor, study sites, and internal associates.- Engaged in clinical trial management on a day to day level- Coordinated project meetings and produce quality minutes- Trained new resources - Identified and resolved of site discrepancies.- Audits: assisted to self-inspection and external audits.- Participated in budgeting process.

Licenciada En Biotecnología, Biotechnology

Técnica Universitaria En Biotecnología, Biotechnology