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QA Manager

Location:
Nordend-West, Hesse, Germany
Posted:
April 07, 2021

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Resume:

Personal Data

Date of birth: **.**.****

Place of birth: Azerbaijan

Marital Status: married

Education

03.2011 – 11.2015 PhD Study in Natural Science, University of Heidelberg (Dr. rer.nat), magna cum laude

10.2008 – 05.2010 Master Study “Cancer Biology”, University of Heidelberg, Germany

09.2003 – 05.2007 Bachelor Study “Biology”, Azerbaijan State University

Work Experience

09.2019 – now Senior QA Manager EMEA; Hoya Surgical Optics GmbH, Frankfurt

Leader of the QA Team EMEA (4 FTE) that is responsible to manage all post-production activities as a Distributor, an Importer and EC-Rep, that includes also supplier and distributor management

Ensuring ongoing compliance with MDD/MDR and ISO 13485:2016 requirements

Management representative (QMB) according to ISO 13485:2016

Supporting the sales and marketing organizations in quality related inquiries and manages any quality issues with customers, suppliers and distributors

07.2018 – 07.2019 Team Leader Production, DiaSorin Deutschland GmbH, Dietzenbach

Leading a Team of 12 FTE

Weekly production planning and documentation of production according to GMP compliance

Initiation, analysis and documentation of change request, out of specification (OOS), deviation (NC) and corrective and preventive action (CAPA)

Performance and documentation of validation and device qualification

Creation and adaptation of QMS documents

Process optimization and implementation of the workshops

Ensuring proper project implementation (FDA registration, product launch) and their internal and external documentation

12.2017 – 06.2018 Supervisor, Product Quality, DiaSorin Deutschland GmbH, Dietzenbach

Leading a team of 7 FTE

Further product development

Validation of products for FDA registration and a new product launch

05.2011 - 07.2015 Research Associate; PhD thesis on “Role of Endosialin during Atherosclerosis Progression”, German Cancer Research Center, Heidelberg

Project management skills while leading projects in parallel

Leading a team of 4 to generate experimental models and to conduct the research

Working with collaborators

02.2010-05.2010 Internship (Research project) Merck KGaA Darmstadt

Working within a project evaluating a novel biomarker candidate

Understanding how drugs are successfully discovered,

developed and brought to market

Other Skills & Awards

TÜV Rheinland Expert Quality Management Medical Devices International

Auditor in the medical device industry

Scholarship for PhD position Helmholtz International Graduate School for Cancer Research

European Business Level A & B : Business plan, Marketing and Sales, Financial

Competence Licence (EBCL) Planning, Investment Analysis and Efficiency Analysis

German Academic Exchange Scholarship for 4 semester Master Study in Germany

Service (DAAD)

Languages German - fluent

English - fluent

Turkish - fluent

Russian - fluent

Azeri - mother tongue

Hobbies Learning new languages, Travelling, Meeting people

Dr. Zulfiyya Hasanov

Felix-Kracht-Str 15, 60486 Frankfurt

Mobil: +49-176-********

E-Mail: adlh78@r.postjobfree.com



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