Merve

Summary


Working Experience


Company??Applied Medical Europe B.V. Netherlands??Date

Role: Internal Auditor

Responsibilities

o Preparing annual schedule for internal audit process covering the Europe facilities
o Conducting the assigned audits as a Lead Auditor
o Preparing the company for the external audits
o Supporting Sterility related processes (Monitoring the cleanroom, radiation dose audits, EO Sterilization facility related processes)
o Microbiological & QMS related consultations


Company??Fresenius Medical Care??Date


Role: Quality Assurance Specialist & Supplier Lead Auditor & Global Corporate Auditor

Previous; Quality Assurance Specialist & Supplier Lead Auditor
Previous; Quality Assurance Specialist
Previous; Quality Assurance Responsible

Contributions to the company;

o Preparing Project Plan for plant moving project
o Prevention of Endotoxin Formation and Biofilm Formation in Production Line and Product
o Renewing Entire Documentation System
o Adaptation to MDR, ISO 13485:2016, ISO 9001:2015 after revisions
o Preparing a Golden Standard for Process Validation by Using Statistical Terms from Scratch
o Start-up to Statistical Process Control from Scratch
o Start-up to Acceptance Sampling Plans from Scratch
o Develop inspection processes, test methods and quality plans
o Start-up to Good Documentation Practices (GDP) from Scratch
o Start-up to Microbiological Analyses in Plant from Scratch
o Start-up auditing suppliers as a headquarter approved auditor
o Supporting Corporate office to audit Fresenius Plants as a headquarter approved corporate auditor
o Start-up of supplier quality management system
o Start-up CAPA management with Qtrak
o Start-up electronic documentation and supplier management system
Responsibilities;

• Performing Supplier Audits

• Performing Corporate Audits

• To implement MDSAP, ISO 13485, ISO 9001, ISO 17025, ISO 14971, ISO 62366, ISO 13958, ISO 13959 standards requirements, being leader as an SME

• Managing Corrective and Preventive Action System over the plant and departments by using QTRACK software as a SME, communication with corporate office regarding CAPA, training employees on CAPA management and root causes

• Configuration and management of Quality Documentation System by using QDMS, First Point, QDOK and also manual system as a SME, coordination with corporate office regarding documentation

• Determination specifications for product by researching in standards

• For Supplier Quality Management, being a leader as a SME, coordination with corporate office regarding Supplier Quality Management

• For Customer Complaints Management, being a leader as a SME, coordination with corporate office regarding Customer Complaints

• Communication with Germany Head Office,

• Supporting calibration activities

• Being a consultant for Microbiology, Biotechnology, Biochemistry and Molecular Biology

• Preparing Stability Study and Process Validation Protocols and Process Validation Reports with coordination of corporate office

• Being a leader for Statistical Applications for all departments

• Being a leader for Risk Assessment (FMEA, Chart, etc.)

• Managing "Quality Circle Teams", quality circles' process development practices

• Competence, awareness and training of white and blue collar employees about Quality Management Systems and about company policies

• Preparing some parts of Technical File,

• Ensuring product quality, preparing biocompatibility reports, assessing product risks,

• Generating an "Consolidated Management System" as a SME including the mentioned standards for all departments QC, Production, Maintenance, Planning, Procurement etc.

• Project Management on Quality;

• Generating projects for "Quality Management Tools" for all integrated management systems

• Coordinating projects for "Quality Method Development" processes.

• Quality Management of other projects

• Reason to leave the job; Plant has been moved to another city

Company?Eti Food Co???Date –

Role: Quality Engineer

Contributions to the company;

o Starting Salmonella Control in Chocolate with PCR from Scratch
o Starting up a Faster Method for Detection of Molds
o Establishing a laboratory for microbiological analyses
o Conducting quality management system especially for the laboratory
Responsibilities;

• Applying BRC, ISO 9001, ISO 22001 standards at chocolate factory for 8 production line.

• Standard Practises for all stages of production –from raw material acceptance to transportation- for quality, production, maintenance, QC analyse planning, executing QC analyses for microbiology, procurement for QC.

• Management of all documentation processes for quality control of chocolate plant's products.

• Ensuring implementation of legal regulations related to Food & Environment and related integrations

• Environment and Waste Management, Waste storage management, removing and recycling processes management, sustainability projects.

• Managing Quality Management System of Chocolate Plant's QC lab,

• Training of white and blue collar employees about Allergens, Food Safety and Quality Systems (2000 man x hour training)

• Applying genetic applications to microbiological analyses (such as genetic detection methods of bacteria)

• Control of the hygiene in whole plant as a Microbiological Expert

• Reason to leave this job: Moving to another city because of marriage

Company?BioDPC???Date

Role: Product Specialist (Application Specialist)

Responsibilities;

• Training hospital employees on how to use medical devices

Company?Hastel Food Co???Date

Role: Quality Engineer

Contributions to the company;

o Adaptation to ISO 22000, ISO 18001 and ISO 9001 from Scratch
o Managing quality system
o Prevention of Molds in Product by Using a Special Enzyme from Scratch
o Establishing a laboratory for microbiological analyses
Responsibilities;

• Application of ISO 9001, ISO 22001 standards at whole plant properly for 5 production line.

• Standard Practises - all stages of production –from raw material acceptance to transportation, for quality, production, maintenance, production planning, procurement, R&D processes.

• Managing entire Quality Management System, sole responsibility

• Conducting Audits

• Responsibility of management of all documentation processes.

• Ensuring implementation of legal regulations related to Food & Environment and related integrations

• Environment and Waste Management, Waste storage management, removing and recycling processes management, sustainability projects.

• Managing Quality Development Projects for entire plant,

• Control of the hygiene in whole plant as a Microbiological Expert

• Training of white and blue collar employees about Food Safety and Quality Systems

Education

Master’s; (GPA: 98,5 / 100)

Hacettepe University Science Institute, Quality & Conformity Assessment Engineer; Date

(Courses: *Probability and Statistics for Engineers *Quality Management *Quality Engineering in Product and Process Design *Quality Management Systems and Inspection *Quality Control *Designing and Analyzing of Engineer Experiments *Metrology and Calibration *Engineering Management *Project Planning and Control *Lean Production Systems.
Graduation Project on: Validation of production systems by using Design of Experiments, Accepting Sampling and Statistical Applications)

Master’s; (GPA: 84 / 100)

Mehmet Akif Ersoy University Science Institute, Biology, Molecular Biology and Genetics; Date

(Master thesis (Ochratoxin Levels of Wines): Detection of ochratoxin levels in wines, Courses on Cancer Biology, Molecular Biology and Genetics)


Bachelor’s; (GPA: 2.35 / 4.00)

Ege Üniversitesi – Science Faculity – Biochemistry & Biotechnology (50% in English); Date


Internships

• TÜBTAK MAM, Gene Engineering Institute, 2007
• Akdeniz University Biochemistry Laboratory, 2008

Working Student, research

• Mehmet Akif Ersoy University, Food Analyze Laboratory,


Additional Qualification



Certificates


Related with medical quality management
• MDSAP ISO 13485:2016 TÜV-SÜD BadHomburg / Germany
• ISO 9001:2015 Lead Auditor Approved by IRCA
• ISO 13485:2016 TÜV-SÜD BadHomburg / Germany
• ISO 13485: 2016 and MDR , KIWA MEYER
• ISO 13485:2016 Internal Auditor, BSI – 08.2018
• ISO 13485:2003, Kiwa – 10.2016
• Medical CE – Medical Device Regulation 2017/745 (MDR), Kiwa – 10.2016
Related with General Quality Management System and Auditing
• ISO 9001:2015 Quality Management System TUV-SÜD / 2017
• ISO 9001:2015 Quality Management System Internal Auditor BSI / 2018
• ISO 9001:2008 Quality Management System and Internal Auditor, BGD Danismanlik-2010
• ISO 9001:2008 Quality Management System, Kimyagerler Dernegi-2009
• GMP (Good Manufacturing Practices), Kimyagerler Dernegi – 2012
• EN 62366-1:2015, Markcert – 10.2017
• PD IEC 62366-2:2016, Markcert
• ISO 19011, Uzman Sertifika – Most current 05.2019
• ISO 14001, Uzman Sertifika - Most current 05.2019
• ISO 18001 (OHSAS), Uzman Sertifika - Most current 05.2019
Related with laboratory quality management
• Method Validations and Uncertanity of Measurement in Microbiological analysis, Kare Validasyon
• Uncertanity of Measurement in Chemical Analysis, Kare Validasyon
• TS EN ISO IEC 17025, Kare Validasyon
Related with Project management and computer programmes
• Basic Project Management, Fresenius Medical Care Learning Centre – April 2018
• Trackwise Qtrack / QDATA / QCOMPLAINT (Related with Corrective and Preventive Action Management)
Fresenius Medical Care Learning Center
• QDOK (Quality Document Management System) Fresenius Medical Care
• QDMS (Quality Documentation Management System) (Non certificated training), Eti Gida LTD STI
• SAP (System, application and products) (Non certificated training), ?Eti
Related with Food Quality Management System
• HACCP ( ISO 22000) Food Safety Management System, Kimyagerler Dernegi
• ISO 22000:2005 Internal Auditor, BGD Danismanlik – 2010
• Sorumlu Müdürlük (Responsible Manager for Food Industry), Kimyagerler Dernegi – 2009
Courses – General
• Statistical Process Management, Fresenius Medical Care
• Risk Management (Process FMEA), Fresenius Medical Care
• Filter and Filteration Process Validation, Sartorius
• Europen Union Projects, Biyokimyagerler Dernegi
• Dangerous Chemicals, TÜBITAK
• Hybridoma Technology, TÜBITAK
• Biosafety, TÜBITAK
Projects


o Adaptation to ISO 22000, ISO 18001 and ISO 9001 from Scratch
o Determination of Ochratoxin Levels in Wines
o Prevention of Molds in Product by Using a Special Enzyme from Scratch
o Starting Salmonella Control in Chocolate with PCR from Scratch
o Prevention of Endotoxin Formation and Biofilm Formation in Production Line and Product
o Renewing Entire Documentation System
o Adaptation to MDR, ISO 13485:2016, ISO 9001:2015
o Preparing a Golden Standard for Process Validation by Using Statistical Terms from Scratch
o Preparing a Golden Record for Supplier Process Monitoring from Scratch
o Startup to Statistical Process Control from Scratch
o Startup to Acceptance Sampling Plans from Scratch
o Startup to Good Documentation Practices (GDP) from Scratch
o Defining a Faster Method for Detection of Molds* (Working with a Team)
o Startup to Microbiological Analisys in Plant from Scratch
Languages

English
Turkish

Hobbies

Playing Guitar
Watching action films
Theatre
Travelling and Exploring new cities/countries
Swimming


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