TBtanem bahşi
@tanembahi
GMP Compliance Specialist with a focus on quality assurance.
TurkeyWhat I'm looking for
I am a dedicated GMP Compliance Specialist with a strong foundation in both theoretical and practical knowledge gained during my education. My experience in the pharmaceutical industry has equipped me with the skills necessary to ensure compliance with industry regulations and to lead internal and external audits effectively. I believe my disciplined work ethic and attention to detail will contribute positively to any laboratory environment.
Throughout my career, I have successfully managed quality assurance processes, including the preparation of regulatory submissions for international clients and the implementation of corrective actions based on audit findings. My goal is to leverage my expertise to provide innovative solutions that align with the objectives of the organization I work for, while continuously developing my skills in the field.
Experience
Work history, roles, and key accomplishments
GMP Compliance Specialist
Sanovel İlaç
Aug 2024 - Present (11 months)
Led internal and external GMP audits to ensure compliance with industry regulations, identifying potential gaps and driving continuous improvement initiatives. Acted as a key liaison for contract manufacturing clients, ensuring all operations met GMP requirements and regulatory updates were implemented.
International Regulatory Affairs Assistant Specialist
World Medicine Pharmaceutical Company
Dec 2023 - Aug 2024 (8 months)
Managed communication with international clients and prepared regulatory application dossiers for European countries. Oversaw variation and DL management until application acceptance by authorities, and initiated change notifications for post-submission modifications.
Quality Assurance Specialist
MAXICELLS İLAÇ SANAYİ A.Ş.
Aug 2023 - Dec 2023 (4 months)
Managed analysis applications, Ministry correspondences, and KÜB-KT updates in line with domestic and international licensing requirements. Tracked TİTCK and national/international legislation related to licensing, and updated SOPs.
Quality Assurance Assistant Specialist
MAXICELLS İLAÇ SANAYİ A.Ş.
Sep 2021 - Aug 2023 (1 year 11 months)
Supported licensing processes, drafted Standard Operating Procedures, and maintained the Quality Management System according to cGMP requirements. Contributed to ensuring compliance with regulatory standards and internal quality policies.
Laboratory Intern
Microne Sağlık Ve Bilişim Teknolojileri San. Tic. Aş.
Oct 2020 - Nov 2020 (1 month)
Completed a 10-day internship focusing on nanotechnology applications. Gained practical experience in a health and information technologies environment.
Translator / Interpreter
Soylu Patent
Aug 2019 - Dec 2020 (1 year 4 months)
Provided translation and interpretation services for patent-related documents and communications. Supported the intellectual property services sector with linguistic expertise.
Laboratory Intern
Next Genetic Center
Jan 2019 - Feb 2019 (1 month)
Participated in a laboratory internship focusing on genetic research and analysis. Assisted with various laboratory procedures and data collection.
Education
Degrees, certifications, and relevant coursework
Yıldız Teknik Üniversitesi (YTÜ)
Lisans, Moleküler Biyoloji ve Genetik
Lisans eğitimim süresince aldığım teorik ve pratik bilgilerin yanı sıra grup çalışması, çalışma disiplini, laboratuvar çalışma kültürü, öz disiplin ve titiz çalışma özellikleriyle gerek rutin laboratuvarda gerekse özel laboratuvardaki çalışmalarda başarılı olacağıma inanmaktayım. Bu özelliklerim ve eğitimim ile laboratuvarda çalışarak kendimi geliştirerek ilerlemek, çalışacağım kurumun hedef ve is
University of Cambridge
Certificate, English Language
Completed the First Certificate in English from the University of Cambridge.
University of Cambridge
Certificate, English Language
Obtained the Cambridge ESOL Level 1 Certificate in ESOL International.
University of Cambridge
Certificate, English Language
Achieved the Key English Test from the University of Cambridge.
İstanbul Üniversitesi
Seminar, Molecular Biology and Genetics
Attended a 3-day seminar on molecular biology and genetics.
Availability
Location
TurkeyAuthorized to work in
Job categories
Interested in hiring tanem?
You can contact tanem and 90k+ other talented remote workers on Himalayas.
Message tanemFind your dream job
Sign up now and join over 100,000 remote workers who receive personalized job alerts, curated job matches, and more for free!
