Summary
Overview
Work History
Education
Skills
Certification
Languages
Timeline
Generic

Christelle Dernikoghossian

PharmD - Quality Specialist
Amman, Jordan

Summary

Proactive and enthusiastic quality specialist with experience in different sectors of the Pharmaceutical Field. Reliable and organized team player aiming to enhance the quality standards within the Pharmaceutical Industry. Proven ability to manage efficiently different tasks ranging from Quality Management System to Product Quality to Third Party Management.

Overview

5
5
years of professional experience
4
4
Certifications
5
5
Languages

Work History

Senior Country Quality Specialist - Levant & Iran

Sanofi
2023.07 - Current
  • 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

Country Quality Specialist - Levant

Sanofi
2019.12 - 2023.07
  • 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


Healthcare Consultant/ Clinical Research Associate

Center for Clinical and Health Outcome for Access
2019.06 - 2019.10
  • 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

Education

Doctor of Pharmacy -

Lebanese American University
Beirut, Lebanon
2001.04 -

Bachelor of Science in Biology -

American University of Beirut
Beirut, Lebanon
06.2014

Skills

  • Time Management

  • Interpersonal Communication

  • Problem Solving

  • Adaptability and Flexibility

  • Time Management

Certification

Auditor Certification - Sanofi

Languages

Arabic
English - Native
French - Native
Arabic - Native
Armenian - Proficient

Timeline

Senior Country Quality Specialist - Levant & Iran

Sanofi
2023.07 - Current

Country Quality Specialist - Levant

Sanofi
2019.12 - 2023.07

Healthcare Consultant/ Clinical Research Associate

Center for Clinical and Health Outcome for Access
2019.06 - 2019.10

Doctor of Pharmacy -

Lebanese American University
2001.04 -

Bachelor of Science in Biology -

American University of Beirut
Auditor Certification - Sanofi
Good Distribution Practices - Sanofi
Interprofessional Education Stimulation & Impact on Self-Assessment & Knowledge of Teamwork
Basic Life Support - American Heart Association
Christelle DernikoghossianPharmD - Quality Specialist