Christelle Dernikoghossian

• Managing Quality Alerts and Recalls with internal team as well as relevant health authorities
• Ensuring appropriate quality oversight process of locally managed subcontractors for all GxP and health-regulated activities:

- Perform Initial Qualification

- Manage Quality Agreement initiation and review

- Perform Routine Audits

- Solving any issue that could arrive internally or with MOH

• Audit and Inspection Readiness

- Initiate in the quarterly running of the Inspection Readiness Tool

- Support in any audit or inspection preparation and related follow-ups and CAPAs

• GxP Computerized Systems:

Ensure the maintenance of an up-to-date local inventory, together with relevant functions and that local computerized system in use within the country for GxP activities are in compliance with regulations and standards

• Change Management:

Implement the process to manage the changes that may impact GxP or health-regulated process or operations by following multidisciplinary exchanges and action plans as applicable

• Deviations Management and CAPA Management:

- Implement the process to manage deviations & CAPAs related to GxP and health-regulated activities

- Help in establishing the appropriate CAPA for deviations, where applicable

- Follow-up on the implementation of the planned CAPAs and their effectiveness measurement

• Managing of country Quality Documents related to GxP activities
• Ensuring the detection of risks along with the escalation, investigation, and adequate action plan drafting
• Managing temperature excursions that occur during inbound shipments and during local storage

• Managing of country Quality Documents related to GxP activities
• Managing of deviations and their related CAPAs related to GxP activities
• Managing change controls that may impact GxP process or operations
• Ensuring an appropriate quality oversight process of locally managed subcontractors for all GxP and health-regulated activities

- Involvement on selection process of GxP Third Parties

- Qualification and Management of Quality Agreement with all GxP Third Parties

- Performance of audits

• Supporting in any audit or inspection preparation and related CAPAs
• Ensuring the classification / validation of any local computerized system in use for GxP activities
• Ensuring the detection of risks along with the escalation, investigation, and adequate action plan drafting
• Managing product related quality events (quality alerts, recalls)
• Managing temperature excursions that occur during inbound shipments and during local storage
• Performing the induction training for newcomers as well as the management of routine quality trainings to GxP departments

• CRA:

Designed and provide the appropriate trainings to physicians
Monitored progress throughout the duration of the trial

• Healthcare Consultant:

Conducted research on different projects related to the
insurance industry

Consulted with healthcare professionals on the results and drew conclusions