Merve Gürbüz Bozkurt - Qualified Person

Q: Where is Merve based?

Merve is based in Neu-Ulm, Germany and can operate in on-site , hybrid , and remote work models.

Q: What languages does Merve speak?

Merve speaks the following languages: Turkish (Native), English (Advanced), German (Elementary) .

Q: How many years of experience does Merve have?

Merve has at least 10 years of experience. During this time, Merve has worked in at least 5 different roles and for 2 different companies . The average length of individual experience is 2 years and 1 month . Note that Merve may not have shared all experience and actually has more experience.

Q: What is Merve's latest experience?

Merve's most recent position is Qualified Person at Drogsan Pharmaceuticals .

Q: What companies has Merve worked for in recent years?

In recent years, Merve has worked for Drogsan Pharmaceuticals .

Q: Which industries is Merve most experienced in?

Merve is most experienced in industries like Pharmaceutical and Manufacturing .

Q: Which business areas is Merve most experienced in?

Merve is most experienced in business areas like Quality Assurance (QA) , Research and Development (R&D) , and Production/Manufacturing .

Q: Which industries has Merve worked in recently?

Merve has recently worked in industries like Pharmaceutical .

Q: Which business areas has Merve worked in recently?

Merve has recently worked in business areas like Quality Assurance (QA) and Production/Manufacturing .

Recommended expert

Neu-Ulm, Germany

Experience

Mar 2023 - Nov 2023

9 months

Ankara, Turkey

Qualified Person

Drogsan Pharmaceuticals

Responsibility for batch release as per EU guidelines by ensuring the requirements have been met.
The batch and its manufacture comply with the provisions of the marketing authorisation (including the requirements for importation where relevant).
Manufacture has been carried out in accordance with GMP.

Feb 2021 - Mar 2023

2 years 2 months

Ankara, Turkey

Quality Assurance CTD-Finished Product Group Executive

Drogsan Pharmaceuticals

Management for detailed preparation and technical control of quality document parts for CTD documents for export dossier applications and variations.
Management for detailed and technical control of quality document parts for CTD documents for variations for local MOH.
Monitoring and management of supplier and authority (both local and export) demands and changes in terms of quality.
Preparation and revising Master Batch Records for products and ensuring that MBRs are current and effective that production staff performs production activities according to current MBRs.
Reviewing and ensuring test methods, specifications, and technical documents according to the latest revisions of authority regulations and standards.
Supervisor for In Process Control Team at production and management in process control activities for product quality.
Planning and tracking calibration activities in plant and control of certificate compliance.
Planning and carrying out supplier audits.
Carrying out internal audits.

Jun 2016 - Feb 2021

4 years 9 months

Ankara, Turkey

Quality Assurance Specialist

Drogsan Pharmaceuticals

Monitoring and management of Change Control, Deviation, OOS, CAPA, Customer Complaints.
Performing process validation studies and preparation of protocol and reports.
Reviewing of analytical method validation protocol and reports.
Planning and carrying out supplier audits.
Carrying out internal audits.

May 2015 - Jun 2016

1 year 2 months

Ankara, Turkey

R&D Laboratory Specialist

Turktipsan A.Ş.

Performing analytical method validation studies.
Preparing CTD- Module 3: Quality parts for registration.
Literature review and reporting for new projects.
Taking part in TUBITAK Grant Programme.

Apr 2013 - May 2015

2 years 2 months

Ankara, Turkey

Quality Control Analyst

Turktipsan A.Ş.

Analyzing the finished product, raw materials, packaging materials and recording the results.
Preparing and revising related instructions.

Summary

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

Skills

Ms Word
Ms Excel
Ms Powerpoint
Matlab
Chemcad
Sap

Languages

Turkish

Native

English

Advanced

German

Elementary

Education

Oct 2020 - Mar 2022

Marmara University

MSc, Engineering Management · Engineering Management · İstanbul, Turkey

Oct 2007 - Jan 2012

Yeditepe University

BEng, Chemical Engineering · Chemical Engineering · İstanbul, Turkey

Oct 2003 - Jun 2007

Çankaya Milli Piyango Anadolu High School

English · Ankara, 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

Profile

Created

September 2025

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Frequently asked questions

Do you have questions? Here you can find further information.

Where is Merve based?

Merve is based in Neu-Ulm, Germany and can operate in on-site, hybrid, and remote work models.

What languages does Merve speak?

Merve speaks the following languages: Turkish (Native), English (Advanced), German (Elementary).

How many years of experience does Merve have?

Merve has at least 10 years of experience. During this time, Merve has worked in at least 5 different roles and for 2 different companies. The average length of individual experience is 2 years and 1 month. Note that Merve may not have shared all experience and actually has more experience.

What roles would Merve be best suited for?

Based on recent experience, Merve would be well-suited for roles such as: Qualified Person, Quality Assurance CTD-Finished Product Group Executive, Quality Assurance Specialist.

What is Merve's latest experience?

Merve's most recent position is Qualified Person at Drogsan Pharmaceuticals.

What companies has Merve worked for in recent years?

In recent years, Merve has worked for Drogsan Pharmaceuticals.

Which industries is Merve most experienced in?

Merve is most experienced in industries like Pharmaceutical and Manufacturing.

Which business areas is Merve most experienced in?

Merve is most experienced in business areas like Quality Assurance (QA), Research and Development (R&D), and Production/Manufacturing.

Which industries has Merve worked in recently?

Merve has recently worked in industries like Pharmaceutical.

Which business areas has Merve worked in recently?

Merve has recently worked in business areas like Quality Assurance (QA) and Production/Manufacturing.

What is Merve's education?

Merve holds a Master in Engineering Management from Marmara University and a Bachelor in Chemical Engineering from Yeditepe University.

Does Merve have any certificates?

Merve has 11 certificates. Among them, these include: General Metrology And Calibration Training, Quality Risk Management - FMEA Training, and Stability Studies In Medicinal Products For Human Use.

What is the availability of Merve?

Merve is immediately available for suitable projects.

What is the rate of Merve?

Merve's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.