プロフィール詳細

プロジェクトを作成

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Damla V.に依頼

Turkey

QA RA Consultant - Medical Device and Pharmaceutical Industry

プロフィール概要

Hi, I have over 15 years of QA/RA experience in a Pharmaceutical and Medical Device industry. My Specialties -Experienced in technical file documentation with a focus on medical devices (Class I and Class IIa). - 5+ years of writing experience in the medical device industry. - Experienced in accordance with MDD and MDR requirements for medical products - CE Mark certification processes - Risk Management File documentation as per ISO 14971 - Usability Engineering Reports - ISO 62366 - ISO 13485 implementation certification and recertification -ERP Software Quality module implementation projects (SAP-QM) -Quality Management System Software implementation projects (BPLM, Trackwise, SciLife, QDMS, etc) -Supplier Management studies (Audit, Approval, Qualification, and periodical performance reviews) - Nonconformity Management, CAPA, and change control management processes. -Management Review Meeting reports -Also I have experience in Medical device applications UTS (Turkish Medical Device Tracking System) and Turkish MoH. Also all kinds of Turkish regulations related to medical devices. If you need any assistance with these services, I would be glad to help you. Look forward to working with you! Kindest Regards, Damla

専門分野

• ★ Medical Devices
• ★ ISO 13485
• ☆ Microbiology
• ☆ Horticulture
• ☆ Pharmaceutical Sciences
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 14971
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Risk Management
• ☆ Management Consulting

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Technical Writing, Copywriting, General Proofreading & Editing, Translation

Research Gap Analysis

Consulting Healthcare Consulting, Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Data & AI Statistical Analysis

Product Development Manufacturing, Quality Assurance & Control (QA/QC)

職務経験

QA RA Consultant - Medical Device and Pharmaceutical Industry

Self employed

1月 2021 - 現在

QA/RA Manager

Pharma & Medical Device Company

12月 2016 - 1月 2020

Lab supervisor, microbiology lab

Baxter Healthcare

10月 2009 - 7月 2016

学歴

MS Horticulture and Agronomy

Ordu University

2月 2021 - 8月 2023

MSc - Horticulture (Agriculture)

Ordu University

9月 2021 - 7月 2023

Bachelor - Biology (Science)

Bursa Uludağ Üni̇versi̇tesi̇

9月 2005 - 6月 2009

Lab Intern (Cancer Biology)

VIB-UGent Center for Plant Systems Biology

9月 2008 - 1月 2009

Exchange student (Science)

Ghent University

9月 2008 - 1月 2009

BSc. Biology

Uludag University

2005 - 2009

認定資格

• MDR Technical Documentation Training

  EUMed

  5月 2021 - 現在

• ISO 9001:2015 Internal Auditor

  Kiwa

  2月 2020 - 現在

• ISO 13485:2016 internal Auditor

  Kiwa

  10月 2019 - 現在

出版物

JOURNAL ARTICLE

Damla Varol, Saim Zeki Bostan (2025). Bioactive Components and Aflatoxins Changing According to the Farming Systems in Hazelnut . Applied Fruit Science.

Damla Varol, Saim Zeki Bostan (2025). Erratum to: Bioactive Components and Aflatoxins Changing According to the Farming Systems in Hazelnut . Applied Fruit Science.