Yalçın KURT
25.04.1967 yılında Babaeski ilçesine bağlı Alpullu kasabasında doğdum. İlk,orta ve Lise öğrenimimi Alpullu’ da tamamladıktan sonra Hava Harp Okulunu kazanarak öğrenim hayatıma devam ettim. Aynı yıl Yıldız Teknik Üniversitesi Fizik bölümünü kazanınca Hava Harp Okulundan ayrılarak öğrenim hayatıma İstanbul’ da devam ettim. 1988 Yılında Yıldız Teknik Üniversitesini bitirdim.
1992 yılında kariyer hayatıma Eczacıbaşı İlaç Firmasında GMP Uzmanı olarak başladım. 16 yıl sonunda Sorumlu GMP Uygunluk Uzmanı olarak ve yaşla emekliliğimi isteyerek firmadan ayrıldım. Aynı yıl Koçak İlaç Çerkezköy de GMP Group Manager olarak çalışmaya başladım. Kısa bir süre sonra buradan da ayrılarak GECH (General Electric Health Care) ‘ in Türkiye de ki ilk ilaç fabrikasının kurulumunda görev aldım ve 8 yıl Kalite Güvence Müdürü olarak çalıştım. 8 yıl sonra GEHC den ayrılarak AİS/POLİFARMA ilaç tesislerinde Kalite Direktörü olarak 1 yıl çalıştım. Bu süre sonunda VEM İlaç San Tic A.Ş. ye geçerek orada da 4 yıl Kalite Güvence Müdürlüğü, 3 yıl da Kalite Direktörlüğü görevlerinde bulundum. 2016 yılında İpsum Validasyon Eğitim Ve Danışmanlık Ltd. Şti.’ nin kurucu 3 ortağından biri olarak iş hayatıma kendi firmamda devam etmeye başladım.2019 yılında ise GMP Academia Eğitim Denetim Ve Danışmanlık Ltd.Şti. ni kurdum.Bu firmaların çatısı altında yurt içi ve yurtdışı ilaç firmalarına eğitim, danışmanlık ve denetim hizmetleri vermeye devam etmekteyim. 4. Dan Karate Do Antrenörü ve Bölge hakemiyim. Evli ve bir kız babasıyım.
CAREER SUMMARY
GMP SPECIALIST / QA SPECIALIST / GMP COMPLIANCE CHIEF / GMP GROUP MANAGER / QA GROUP MANAGER/ QUALITY GROUP DIRECTOR
- Experience on facility design, installation and commissioning
- Experience on EU GMP&FDA GMP
- Experience on equipment qualification, validation and calibration
- Experience on Quality Management Systems
- Experience on Temperature Controlled Warehouse and Vehicle validation
- Supply Chain sector. Managing all activities at Turkey site .
- Problem solving and managing validation teams skills under the high pressure.
- Experience on managing Process/Cleaning Validation teams.
- Experience on GMP and ISO 9001:2015 audits
- Experience on Vendor audits
- Experience on Risk Management
AREAS OF EXPERTISE
- EU GMP
- Project Management
- c GMP Audits
- GXP / ISO 9001:2015 Audits
- Relations with Ministry of Health
- Process and Cleaning Validation
- Equipment Validation and Calibration
- GMP Compliance
- Team Management
- Qualification&Validation
PROFESSIONAL EXPERIENCE
GMP ACADEMIA CO.
Founder/QMS Consultant 02.2019 – …….
VEM Pharmaceuticals
QUALITY GROUP DIRECTOR 06.2019 – 01.2022
VEM Pharmaceuticals Group has;
-Biotechnology Site
-Penem/Penicillin Site
-Hormone Site
-Oncology Site
-Sterile&Non Sterile Sites
-İnhaler Site
- Advising and Managing all QA activities of QA
- Advising and Managing all Bacteriology Lab. activities
- Advising and Managing all QC activities (raw material, packaging material, finished product, stability)
- Advising and Managing all qualification and validation activities (equipment, HVAC, method, media fill, CSV, Cleaning etc)
- Being participant of the all authority and customer audits
- Being participant of the all CSV and Data Integrity activities
- Being participant of the Risk Assessment
- Control, reviewing and managing of all quality activities that are executed by the outsource.
- Being participant of the vendor audits.
- Being participant of the FATs., SAT s.
- Organizing Data Integrity audits and trainings.
- Managing all the Aseptic Filling Validation activities. Managing the Project plans of Aseptic Filling Validation team.
- Managing the Project plans of Equipment Validation&Qualification and Calibration team.
VEM Pharmaceuticals
QA MANAGER 10.2016 – 06.2019
- Advising and Managing all QA activities of QA
- Advising and Managing all qualification and validation activities (equipment, HVAC, method, media fill, CSV, Cleaning etc)
- Being participant of the all authority and customer audits
- Being participant of the Risk Assessment
- Control, reviewing and managing of all quality activities that are executed by the outsource.
- Being participant of the vendor audits.
- Being participant of the FATs., SAT s.
- Managing all the Aseptic Filling Validation activities. Managing the Project plans of Aseptic Filling Validation team.
- Managing the Project plans of Equipment Validation&Qualification and Calibration team.
Achievements & Projects (VEM Pharmaceuticals)
- Managing of 20 new laboratory and production system implementation and Computerised System Validati
- 10 Turkish Ministry of Health audit succes
- 1 Croatia Ministry of Health audit succes ( EU GMP)
- 5 Internal CSV and Data Integrity Audit.
- Getting GMP certificate of Biotechnology site, Hormone Site, Penem/ Penicilline Site, İnhaler Site, sterile lines from Turkish mOH
POLİFARMA & AROMA PHARMACEUTICALS 01.2016-10.2016
QA GROUP DIRECTOR
- Advising and Managing all QA activities of QA
- Advising and Managing all Bacteriology Lab. activities
- Advising and Managing all QC activities (raw material, packaging material, finished product, stability)
- Advising and Managing all qualification and validation activities (equipment, HVAC, method, media fill, CSV, Cleaning etc)
- Being participant of the all authority and customer audits
- Managing all the Aseptic Filling Validation activities. Managing the Project plans of Aseptic Filling Validation team.
- Managing the Project plans of Equipment Validation&Qualification and Calibration team.
Achievements & Projects (POLİFARMA&AROMA)
- Designing, installation and commissioning of Aroma Pharmaceutical Site
- Getting GMP certificates to Aroma Pharmaceuticals from Turkish mOH
- Many successful authority audits
- 17 customer audits.
GEHC 08.2008 – 12.2015
QA MANAGER
- Advising and Managing all QA activities of QA
- Advising and Managing all qualification and validation activities (equipment, HVAC, method, media fill, CSV, Cleaning etc)
- Being participant of the all authority and customer audits
- Being participant of the Risk Assessment
- Control, reviewing and managing of all quality activities that are executed by the outsource.
- Being participant of the vendor audits.
- Being participant of the FATs., SAT s.
- Managing all the Aseptic Filling Validation activities. Managing the Project plans of Aseptic Filling Validation team.
- Managing the Project plans of Equipment Validation&Qualification and Calibration team.
Achievements & Projects (GEHC)
- Designing, installation and commissioning of GEHC/Medicheck Radiopharmaceutical Site
- Getting GMP certificates to Aroma Pharmaceuticals from Turkish mOH
- Getting EU GMP Certificate
- Many successful authority audits
SANOFI /ECZACIBAŞI-ZENTİVA İLAÇ SAN.TİC.A.Ş. 12.2006-03.2008
GMP COMPLIANCE CHIEF
- Ensuring Facility G.M.P. compliance
- Managing and participant of Internal audits, Ministry of Health and Licensor audits, Supplier Audits, Unplanned G.M.P. audits, Corrective & Preventive Actions
- Preparation of CAPA s and audit reports
- ERP Systems (SAP, LIMS, DOCUMENTUM) installation Works
- Deviations, Corrective & Preventive Actions and Change Control Management
- Control and approval of IQ / OQ / PQ studies
- Control and approval of Calibration certificates
- Risk management
- Approval of Qualification and Validation Studies
- VIP (Value Development Program) studies
Achievements & Projects (SANOFI)
- FDA GMP Certificate
- MHRA GMP Certificate
- Many authority and customer audits
SANOFI/ECZACIBAŞI-ZENTİVA İLAÇ SAN.TİC.A.Ş. 05.1996-12.2006
QA SPECIALIST
- Participant of Internal audits, Ministry of Health and Licensor audits, Supplier Audits, Unplanned G.M.P. audits, Corrective & Preventive Actions
- Preparation of CAPA s and audit reports
- ERP Systems (SAP, LIMS, DOCUMENTUM) installation Works
- Deviations, Corrective & Preventive Actions and Change Control Management
- Control and approval of IQ / OQ / PQ studies
- Control and approval of Calibration certificates
- Risk management
- Approval of Qualification and Validation Studies
- VIP (Value Development Program) studies
SANOFI/ECZACIBAŞI-ZENTİVA İLAÇ SAN.TİC.A.Ş. 02.1992-05.1996
GMP SPECIALIST
- Performing all equipment qualification and validation studies (HVAC Systems, autoclaves etc.)
- Performing all calibration studies (Balances, temperature etc.)
EDUCATION
1984-1988
- University: Yıldız Technical University
Physics
- High School , Kırklareli Babaeski Alpullu Lisesi
SKILLS & TRAINING & CERTIFICATES LANGUAGE SKILLS
English – Upper Intermediate
Turkish - Native Language
COMPUTER SKILLS
- Microsoft Office (Word, Excel, Powerpoint) SAP
TRAINING
- “TS EN ISO/IEC 17020:2012 Çeşitli Tipteki Muayene Kuruluşlarının Çalıştırılması İçin Genel Şartlar Standartı”, 25-26.10.2017
- ISO 9001:2015 Lead Auditor (QA ALBERK)
- ISO 13485 Medical Devices –Quality Management Systems
- “LEAN MANUFACTURING” Lean Academy,2015, August
- “Ulusal Proton Hızlandırıcı Çalıştayı”,TAEK,18-19.04.2013
- “TS ISO 31000 RİSK YÖNETİM SİSTEMİ”,TSE, 11-13.02.2013
- “HVAC Systems and Environmental Control for Pharma/Life-Science Applications”,Gordon Farquharson, ACEDEMIA, 03&04 September 2013
- “MÜŞTERİ MEMNUNİYETİ”,TSE, 25-26.06.2012
- “Merck Millipore Saf Su&Filtrasyon Sistemleri Semineri”, İNCEKARALAR, 01.11.2012
- “Cleaning Validation on Pharmaceutical Industry”, ACADEMIA,16-17 June 2012
- “Training of Trainer”, 20 April 2012,ANDEM
- “PROTOKOL VE NEZAKET KURALLARI” 01.03.2012, PRİZMA
- “İŞ HAYATINDA YAZIŞMA TEKNİKLERİ VE YAZI DİLİNİN ETKİN KULLANIMI” 27.01.2012, SUNA OKUR
- ‘’DGR REGULATIONS , 01-06 Feb. 2010
- ‘’QA TRAINING’’, GEHC HOLLAND
- ‘’Thermal Validation Seminar’’ , GE,29 May 2009
- ‘’Pressure , Balance, Temperature Calibrations Uncertainty” UNITEST, 13-15 May. 2009
- ‘’Secure Transport of Radioactive Materials’’,TAEK,27-28 Nov. 2008
- ‘’Radiation Protection’’, TAEK, 19.09.2008
- ‘’Basic Radiopharmacy’’ ,Çekmece Nükleer Araştırma ve Eğitim Merkezi, 06-10 October 2008
- ‘’cGMP/Documentation/Change Control’’,ICCE,26-28 August 2008
- ‘’Quality Auditor Certificate’’ , Quality Word, 2009
- ‘’CAPA’’ in the Pharma Industry, IAGT, January,24 th,2007
- ‘’Intensive Upper Intermediate English Course’’,Churchill House,England, 12October-8 November 2003
- ‘’Risk Management’’, IAGT, 29-30 March 2006
- ‘Creative Thinking Techniques, ABC Danışmanlık, 24 May 2005
- ‘’MS Excel 2000’’, ANT Danışmanlık, 27-28 September 2004
- ‘’HVAC Systems-Critical Utilitues Course’’, IAGT, 30-31 May 2005
- ‘’Validation Seminar’’, İlaç ve Kimya Endüstrisi Araştırma ve Geliştirme Vakfı, 31 May-1 June 2001
- ‘’Calibration’’, Metronorm, 21-22 December 1994
- ‘’Microfiltration: Technical&Regulatory State of the Art’’,PALL, 27 March 2000
- ‘’ Self Inspector Certificate’’, TSE, 22-24 November 2000
- ‘’Occupational Health and Safety’’, ROTA, 05.11.1996
- ’’Fire Training’’ , YAN-MA-DAN, 18.11.2002
- ’’ISO 9001:2000 Quality Management System Update Training, Bureu Veritas, 11.03.2003
- ‘’English Upper Intermediate Certificate’’, ASYA
- ‘’Module III :GMP&Validation of Essential Services UNIT A.Validation of HVAC Systems’’, IAGT, 20-21 Eylül 2004
- ‘’Creativity and innovation’’,Eczacıbaşı,1-2.April.2004 (In house training)
- ‘’PROJECT MANAGEMENT ’’,Eczacıbaşı,10-11.June.2002 (In house training)
- ‘ACTIVE CONTENT AND REPORT WRITING’’ ,Eczacıbaşı,28.Nisan.2003 (In house training)
- ‘’TIME MANAGEMENT’’ ,Eczacıbaşı,21.June.2002 (In House training)
- ‘NEGOTIATIONS OF BASIC SKILLS’’ ,Eczacıbaşı,2-3.October.2003 (In house training)
AUDIT EXPERIENCES
-MOH TURKEY
-MHRA
-FDA
-ABBOTT
-MOH GERMANY
-ALPHARMA
-ACTAVIS
-ALTER
-AMDIPHARM
-ASTRA ZENECA
-BAXTER
-BAYER
-BIOPHARMA
-BIOGARAN
-BMS (BRISTOL MYERS SQUIBB)
-BOEHRINGER
-BOUCHARA
-BREKENRIDGE
-COPYFARM
-COPYPHARMA
-CP PHARMA
-CRESCENT
-CURAMED
-DENMARK MOH
-DURASCAN
-FRESENIUS
-GE
-GEHC
-GENUS
-SOUTH AFRICA-MCC
-HANMI
-HELM-DEXCEL
-HEXAL A.G
- ICN POLFA RZESZÒW S.A (POLAND)
-IVAX
-JANSSEN
-JEDAN
-JENSON
-KENT PHARMA
-KOPRAN
-LAB. AGUETTANT
-MERCK
-MERCK DURA
-MERCKLE GmbH
-NOVARTIS
-ORION
-P&G
-PERRIGO
-PFIZER
-PHARMACIA
-PLIVA
-POLPHARMA
-ROCHE
-ROMANIA-PIC
-SANDOZ
-SANOFİ AVENTIS
-SCHERING PLOUGH
-SIEGFRIED
-SMITHKLINE BEECHAM
-SOLVAY DUPHAR
-TAEK
-TEVA
-TGA (MOH AUSTRALIA)
-TIEFENBACHER
-MOH UCRAINE
-MOH JORDAN
-WALMARK
-WOCKHARD UK
-ZENTIVA
-ZYDUS
-MOH CROATIA
-SONUC PHARMACEUTICAL WAREHOUSE (GDP)
-HERKUL PHARMACEUTICAL WAREHOUSE (GDP)
-ALTINISIK PHARMACEUTICAL WAREHOUSE (GDP)
-DINCA PHARMACEUTICAL WAREHOUSE (GDP)
-TURKTIPSAN PHARMACEUTICAL WAREHOUSE (GDP)
-YENICAG PHARMACEUTICAL WAREHOUSE (GDP)
And many more….
REFERENCES
- Orhan KALENDER
QUALITY DIRECTOR M: +905383772730
Canan GÜRDAL
QA MANAGER M: +905414291805
Mehmet CAN
SITE MANAGER M: +905326125878
PERSONAL INFORMATION
Birth date : 25.04.1967 Military Obligation : Completed
Marital Status : Married Driver License: B Class(2005)
Travel Status : Allowed for both Domestic and Abroad