Profile Details

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Hire Damla V.

Turkey

USD 50 /hr

QA RA Consultant - Medical Device and Pharmaceutical Industry

Profile Summary

Hi, I have almost 15 years of experience in a multinational Pharmaceutical and Medical Device company as a QA/RA manager. 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

Subject Matter Expertise

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

Services

• 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)

Work Experience

QA RA Consultant - Medical Device and Pharmaceutical Industry

Self employed

January 2021 - Present

QA/RA Manager

Pharma & Medical Device Company

December 2016 - January 2020

Lab supervisor, microbiology lab

Baxter Healthcare

October 2009 - July 2016

Education

MS Horticulture and Agronomy

Ordu University

February 2021 - August 2023

BSc. Biology

Uludag University

2005 - 2009

Certifications

• MDR Technical Documentation Training

  EUMed

  May 2021 - Present

• ISO 9001:2015 Internal Auditor

  Kiwa

  February 2020 - Present

• ISO 13485:2016 internal Auditor

  Kiwa

  October 2019 - Present