QA Manager
Resume:
Personal Data
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: ********@***.**
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