Qmex (Risk Management, CAPA, Deviation, Change Control, Internal Audits, External Audits)
Seckin Ozguvenir
GMP & GDP Compliance / Quality Assurance & EHS Manager
Sariyer
Summary
Quality & GLP/GMP/GLP Compliance Professional in the pharmaceutical industry with experience period of 21 years; developed an expertise in Quality Management Systems, R&D, Quality Control, Validation& Qualification, Computerized System Validation, Project Management, Risk Management, Regulatory Affairs, Quality Assurance, Quality Compliance, Supplier Management, Audits, Data Integrity, Business Continuity, Risk Assessment, Environment, Health and Safety Management Training, Quality Topics in Wholesale & Pharmaceutical Manufacturing.
Overview
20
20
years of professional experience
Work History
Quality Assurance & EHS Manager
ALLIANCE HEALTHCARE - CENCORA
11.2019 - Current
- Provided leadership, direction and implementation of Quality Management System, GDP and EHS by coordinating Responsible Pharmacists located at 76 Alliance Healthcare Warehouses
- BCPs (Business Continuity Plan) & BIAs (Business Impact analysis)
- Structuring of data modelling systems & software applications.
Quality Operations Manager -Responsible Person
DEVA PHARMACEUTICALS
09.2017 - 11.2019
- Responsible from the Quality Assurance, Quality Control (Chemical& Microbiological), Validation and Qualification Departments.
- Data Integrity, Product Quality Review System, Deviation System, Change Control System, Customer Complaints, Corrective/ Preventive Actions in accordance with TR, EU and FDA requirements.
- Local & Foreign Health Authorities (U.S.FDA, EU etc.) and External company audits
- Responsible Person for Livestock and API products
GMP Compliance & Quality Manager (Devatis EU)
DEVA PHARMACEUTICALS
11.2016 - 09.2017
- Coordination and inspection readiness for Local &Foreign Health Authorities (U.S.FDA, EU etc.) and External company audits for all four Deva sites.
- Establishing and implementing internal and external trainings, internal audits, supplier auditing and evaluation, quality agreements, e-compliance, regulatory compliance, computerized system validation activities,inspection readiness, GAP analyzes for all production facilities.
- Managing, designing and structuring the data modelling system related to quality management electronic systems.
Quality Compliance & Quality Assurance Supervisor
PHARMAVISION PHARMACEUITALS
04.2008 - 11.2016
- Managing and contacting with the multinational customers as a contact person about all quality subjects covering cGMP/cGLP (Product Quality Review System, Deviation System, Change Control, Customer Complaints, CAPA, Risk Management, Computerized System Validations,Master Manufacturing Protochols, Process Validations )
- Readiness, participation& coordination of (National and International) quality & certification Institute & Multinational Company Audits Certification application & management systems (TS ISO 31000 and EN ISO 22000: 2005 .)
- Preparetion of Technical CTD Dossier based on EU and local regulations for Licence Holder submissions (CMC)
Quality Control Lab. Documentation Responsible
Menarini
01.2008 - 03.2008
- Preparation of Raw Material and Final Product Analysis Test Methods &Standart Operation Procedures.
- To follow-up the counterfeit product process.
R&D Analytical Development Lab. Speacilist
BİLİM PHARMACEUTICALS
09.2003 - 12.2007
- Preparation of CTD Dossier according to EU Regulation Requirements.
- Analytical Method Development, Method Transfer and Method Validation Studies through ICH Guidelines.
- Structuring data modelling of computerized Systems connected to Waters SDMS (Scientific Data Management System)
Education
MBA - MBA
Kavrakoglu Management Institute
Istanbul 04.2001 -
Master of Science - International Quality Management
Marmara University
Istanbul 04.2001 -
Bachelor of Science - Chemistry (English)
Istanbul University
Istanbul 04.2001 -
Skills
Extensive Quality/GMP/GDP Knowledge
Affiliations
AmCham, KornFerry Turkey and European Mentoring & Coaching Council (EMCC) -Women Executive Mentorship Program Mentorship
Software
ERP (SAP)
Archer
BCIC
Laboratuary Softwares (Waters, LC Solutıons etc)
Timeline
Quality Assurance & EHS Manager
ALLIANCE HEALTHCARE - CENCORA
11.2019 - Current
Quality Operations Manager -Responsible Person
DEVA PHARMACEUTICALS
09.2017 - 11.2019
GMP Compliance & Quality Manager (Devatis EU)
DEVA PHARMACEUTICALS
11.2016 - 09.2017
Quality Compliance & Quality Assurance Supervisor
PHARMAVISION PHARMACEUITALS
04.2008 - 11.2016
Quality Control Lab. Documentation Responsible
Menarini
01.2008 - 03.2008
R&D Analytical Development Lab. Speacilist
BİLİM PHARMACEUTICALS
09.2003 - 12.2007
MBA - MBA
Kavrakoglu Management Institute
04.2001 -
Master of Science - International Quality Management
Marmara University
04.2001 -
Bachelor of Science - Chemistry (English)
Istanbul University
04.2001 -