A highly skilled, dynamic and passionate pharmaceutical professional with over 15 years' experience in the Pharmaceutical industry across a wide range of functions including; - Qualification&Validation, - CAPA,- Supplier Management,- Audit, - Training, - Risk Management, - Root Cause Analysis, - Process Development, - KPIs, - Internal&External and Regulatory Audits, - Batch Documentation, - Deviation, - Change Control, - Complaint Management Systems.Work as freelancer in european countries. Certified auditor in Pharmaceutical industry, ISO 9001 and GMP, experienced with domestic and international supplier audits in European Area and Russia.Specialties: Quality Compliance Professional, Lead auditor, Quality Risk Management Leader, Inspection Management Professional, Trainer in GxP and ISO Strengths: Positive, Achiever, Learner, Problem Solver and Solution Oriented, Supportive and Team Player.
Freelance
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Quality ConsultantFreelance
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Technology Transfer Customer Management SupervisorAbdi Ibrahim Pharmaceuticals Mar 2019 - Jun 2022Istanbul, Turkey*Coordinate monthly & yearly business review meetings in the scope of quality and supply KPIs *Manage the KPI reporting process, delivers the reports to the customers on a monthly basis*Lead the process improvement projects*Manage customer complaints, perform root cause analysis by leading cross functional teams, define the needed CAPAs, final response to the customer *Organize, and report customer satisfaction surveys. To follow the actions determined in line with the survey outputs -
Deputy Validation ExecutiveSanovel İlaç Jan 2017 - Apr 2018*Act as Deputy Validation Executive and lead validation team.*Prepare and follow the Annual Process Validation Master Plan & Annual Cleaning Validation Master Plan*Training *Organise and issue monthly validation plan*Review process validation protocols & reports*Review cleaning validation protocols & reports*Review computer systems validation protocols & reports*Perform GMP compliance and internal audits -
Qa Validation SpecialistSanovel Dec 2010 - Jan 2017*Prepare process&cleaning&computer systems validation protocols, execution and report process validation activities. *Manage contract manufacturing operations and product transfer activities for solid, semi solid, liquid, sterile products & medical device*Risk Management Project Group Core Member; Create and manage a product spesific Quality Risk Analysis (FMEA, Ishikawa diagram)*Manage documentation, review and approval of all GMP documents*Manage CAPA system; support CAPA request trigerred by CAPA subsystems, manage all aspects of CAPA activities by leading cross functional teams, perform root cause analysis and select the appropriate root cause analyse technic, identify CAPAs, perform effectiveness check. *Perform monthly review meetings and analyze quality data sources and apply statistical techniques*Perform GMP compliance and internal audits
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Qa SpecialistActavis Jun 2010 - Nov 2010*Responsible of all QA activities of the warehouse and ensure the compliance with cGMP, cGDP, MoH and EU regulations*Manage of all GMP compliance activities as deviation management, change control management, CAPAs, trainings, OOS&OOT, customer complaints, quality KPIs. -
Qa Validation SpecialistDeva May 2009 - Oct 2009*Responsible of all Validation activities of the facility and ensure the compliance with cGMP, cGDP, MoH and EU regulations*Handle of all GMP compliance activities as deviation management, change control management, CAPAs, trainings, OOS&OOT, customer complaints, quality KPIs. -
Asistant Qa SpecialistI.E. Ulagay - Menarini Group Dec 2006 - Apr 2008Istanbul, Turkey*Responsible of all QA activities of the sterile&non-sterile manufacturing site and ensure the facility compliance with cGMP, MoH and EU regulations.*Responsible of procedures, practices, systems, controls, process to assure that they conform to GMP/GLP/GDP and requirements.*Handle of all GMP compliance activities as deviation management, change control management, CAPAs, trainings, OOS&OOT, customer complaints & recalls, quality KPIs, annual product review.*Investigate non-conformities & quality issues and performing root cause analysis.*Review batch records and responsible from batch release *SOP management and update procedures due to the guidelines to meet the requirements.*Follow national and international laws, guidelines and regulations regarding GMP.
Eli̇f Güven Education Details
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Pharmacology
Frequently Asked Questions about Eli̇f Güven
What company does Eli̇f Güven work for?
Eli̇f Güven works for Freelance
What is Eli̇f Güven's role at the current company?
Eli̇f Güven's current role is Quality Consultant.
What schools did Eli̇f Güven attend?
Eli̇f Güven attended Marmara Üniversitesi, İstanbul Üniversitesi / Istanbul University.
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Elif Guven
It Manager In Iso 27001 Certified Deris Group Company Ader Systems With 20 Years Of Experience In Intellectual Property And Legal FieldIstanbul -
Elif Güven
Istanbul
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