Merve G. - Qualified Person | FRATCH

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de

Neu-Ulm, Germany

Experience

Mar 2023 - Nov 2023

9 months

Ankara, Turkey

Qualified Person

Drogsan Pharmaceuticals

Responsible for batch release according to EU guidelines, ensuring all requirements are met
Ensured that batches and their manufacture comply with marketing authorization provisions (including importation requirements where relevant)
Oversaw manufacturing carried out in compliance with GMP

Feb 2021 - Mar 2023

2 years 2 months

Ankara, Turkey

Quality Assurance CTD-Finished Product Group Executive

Drogsan Pharmaceuticals

Managed the preparation and technical review of quality document sections for CTD dossiers in export applications and variations
Managed the preparation and technical review of quality document sections for CTD variations for the local Ministry of Health
Monitored and managed supplier and regulatory authority quality requirements and changes (local and export)
Prepared and updated Master Batch Records, ensuring they were current and effective, and that production staff followed them
Reviewed and verified test methods, specifications, and technical documents against the latest authority regulations and standards
Supervised the In-Process Control Team in production, overseeing process control activities for product quality
Planned and tracked calibration activities in the plant, ensuring certificate compliance
Planned and conducted supplier audits
Performed internal audits

Jun 2016 - Feb 2021

4 years 9 months

Ankara, Turkey

Quality Assurance Specialist

Drogsan Pharmaceuticals

Monitored and managed Change Control, Deviations, OOS, CAPA, and customer complaints
Conducted process validation studies and prepared protocols and reports
Reviewed analytical method validation protocols and reports
Planned and conducted supplier audits
Performed internal audits

May 2015 - Jun 2016

1 year 2 months

Ankara, Turkey

R&D Laboratory Specialist

Turktipsan A.Ş

Conducted analytical method validation studies
Prepared CTD Module 3 quality sections for registration
Performed literature reviews and reporting for new projects
Participated in the TUBITAK Grant Program

Apr 2013 - May 2015

2 years 2 months

Ankara, Turkey

Quality Control Analyst

Turktipsan A.Ş

Analyzed finished products, raw materials, and packaging materials, recording results
Prepared and updated related instructions

Summary

Qualified Person with 10 years of experience in pharmaceutical companies in Quality Assurance (sterile and non-sterile products)
Knowledge of GMP, ISO 9001:2015, and international guidelines and regulations (ICH, FDA, WHO, EMA, pharmacopoeias, etc.)
Experienced in managing quality systems (Change Control, Deviation, OOS, CAPA, Customer Complaints) and in analytical and process validation studies
Knowledge of SAP and QMex Quality Management System
Experienced in conducting internal and supplier audits.

Languages

Turkish

Native

English

Advanced

German

Intermediate

Education

Marmara University

Engineering Management · İstanbul, Turkey

Yeditepe University

Chemical Engineering · İstanbul, Turkey

Certifications & licenses

General Metrology And Calibration Training

Turkish Standards Institution

Quality Risk Management - FMEA Training

Figen Yılmaz Eğitim & Danışmanlık

Stability Studies In Medicinal Products For Human Use

Digipharma& Consulting

Cleaning Validation Training

Figen Yılmaz Eğitim & Danışmanlık

Nitrosamine Risk Assessment Report Preparation Training

Figen Yılmaz Eğitim & Danışmanlık

Calibration And Measurement Uncertainty Training

The Swiss Consulting

Audit Training

BTS

GMP Training

BTS

ISO 9001:2015 Internal Auditor Training

Cicert Belgelendirme

ISO 13485: 2012 Internal Auditor Training

The Quality Men

GMP Update Training

Academia

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