Meryama Azizi

Regulatory affairs operations pharmacist, quality departement at GSK

• Algeria
• My current job since July 2014

• Regulatory affairs :
 Ensuring the back up of the regulatory affairs manager (pharmacist technical director) .
 Preparation of required documentation following the local import requirements for the several Registration, Homologation, Renewal & Variations dossiers as a service provider in Algeria for several foreign companies ( Americans, frenchs, Indians….) in order to introduce / maintain their respective products on the Algerian market (medecines, medical devices, dietary supplements…)
 Preparation of required documentation for the Registration, Renewal & Variations following the requirements for local production .
 Submission of: Registration, Renewal & Variations dossiers to the competent authorities
 Monitoring of the various deposits of files (files for submission, registration, renewals) with the competent authorities
 Deposit and monitoring of monthly import declarations, customs declarations, import exceptions and programs.
 Giving advice in order to resolve regulatory issues related to the pharmaceutical development
 Preparing required documents by the Algerian Laboratory of Control of Pharmaceutical Products in order to obtain authority batch release certificates .



• Quality / Quality assurance :
 Continuous training regarding the GMPs
 Implication in the process QMS.
 Performing auto-inspection audits .
 Participating in the processs RCA, risk management, internal audits, deviations and CAPA management.
 Participation in specific projects : production, quality ……..
 Trained to work on trackwise plateforme.

• Services:
 Preparation and submission of required documentation and samples to the Algerian laboratory of control of Pharmaceutical products for batch release.
 Ensure the internal release of finished products

• Compliance / Customer complaints :
 Ensuring the improvement of the customer complaint’s process.
 Reception and recording of the received customer complaints.
 Investigation on the received customer complaints, and ensuring information’s return to the complainers.

• Pharmaceutical packaging :
 Ensuring the improvement of the artwork’s management process.
 Validation and translation of packaging and mock ups (from English to :Arabic / French) following the local requirements of packaging materials .
 Validation and translation of PILs and / or RCPs (from English to: Arabic / French)
 Validation of the promotional materials
 Trained to work on PLM software for artworks management.

Regulatory affairs pharmacist at Biopharm Distribution

• Algeria - Algiers
• November 2012 to July 2014

• to

Ensuring the back up of the regulatory affairs manager (pharmacist technical director) .
Preparation of required documentation following the local import requirements for the
several Registration, Homologation, Renewal & Variations dossiers as a service
provider in Algeria for several foreign companies ( Americans, frenchs, Indians….) in
order to introduce / maintain their respective products on the Algerian market
(medecines, medical devices, dietary supplements…)
Preparation of required documentation for the Registration, Renewal & Variations
following the requirements for local production .
Submission of: Registration, Renewal & Variations dossiers to the competent
authorities
Monitoring of the various deposits of files (files for submission, registration, renewals)
with the competent authorities
Deposit and monitoring of monthly import declarations, customs declarations, import
exceptions and programs.
Giving advice in order to resolve regulatory issues related to the pharmaceutical
development
Preparing required documents by the Algerian Laboratory of Control of Pharmaceutical
Products in order to obtain authority batch release certificates .
Curriculum Vitae
• Quality / Quality assurance :
Continuous training regarding the GMPs
Implication in the process QMS.
Performing auto-inspection audits .
Participating in the processs RCA, risk management, internal audits, deviations and
CAPA management.
Participation in specific projects : production, quality ……..
Trained to work on trackwise plateforme.
• Services:
Preparation and submission of required documentation and samples to the Algerian
laboratory of control of Pharmaceutical products for batch release.
Ensure the internal release of finished products
• Compliance / Customer complaints :
Ensuring the improvement of the customer complaint’s process.
Reception and recording of the received customer complaints.
Investigation on the received customer complaints, and ensuring information’s return to
the complainers.
• Pharmaceutical packaging :
Ensuring the improvement of the artwork’s management process.