Merve (Gürbüz) G.
Qualified Person
Experience
Mar 2023 - Nov 2023
9 monthsAnkara, 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 monthsAnkara, 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 monthsAnkara, 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 monthsAnkara, 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 monthsAnkara, 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
NativeEnglish
AdvancedGerman
IntermediateEducation
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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