Timur Güvercinci
Senior Quality Project Expert and Consultant in the Pharmaceutical Industry
Experience
Jan 2023 - Dec 2024
2 yearsGermany
Senior Quality Project Expert and Consultant in the Pharmaceutical Industry
Self-Employed Consultant
- Sanofi Aventis, Frankfurt/Höchst Site, Manufacturing of Large Molecules – Quality and optimization Projects for operations
- MSD Vet Pharma Friesoythe GmbH, Friesoythe Site, Manufacturing of Veterinary Medicinal Products – Leading a cleaning development and validation project for a new manufacturing area
- Roche Diagnostics Deutschland GmbH, Mannheim Site, Local IT Service Department – Leading Computer System Validation projects
- GMP Consulting for a small size IT-Company for the development of a cloud based documentation management system for the pharmaceutical industry.
- GMP Consulting for a large size IT-Company for the development of a software for the execution of the continued process verification in the pharmaceutical industry.
Jan 2021 - Dec 2023
3 yearsGermany
Senior Director, Head of Quality Cardiopulmonary - Active and Non-Active Medical Devices
Getinge AB
- Management of the quality organization Cardiopulmonary with 170 employees at the sites in Germany and Turkey with 7 direct reports
- Development of all direct reports with individual development plans for the soft skills over the big 5 model and the hard skills acc. a gap analysis
- Leading per dotted line Regulatory Affairs department with one direct and 20 head counts
- Major Improvements in a remediation program of the QMS after a consent decree by the FDA e.g. CAPA Complaint Management System
- Improvement of the global QMS system by a QMS harmonization program of all local sites; Led global QMS harmonization program.
- Management of the FDA inspection preparations at three sites in Germany with a self-developed Trainings Program related to communication and behavior; Led FDA inspection preparation and remediation program for consent decree.
- Responsible Person for Regulatory Requirements (PRRC) according to Art. 15 MDR for the business unit Cardiopulmonary
- Quality Management Representative at the manufacturing site in Hechingen Germany, production Disposables Cardiopulmonary
- Board Member of the management team of the Cardiopulmonary business unit
- Quality Lead for MDR implementation
- Managing Change to a new Notified Body.
Jan 2020 - Dec 2021
2 yearsDarmstadt, Germany
Director, Head of External Supply Quality Processes and Development - Global Quality
Merck Healthcare KGaA
- Improve global QMS for External Supplier and CMO Management by integration of a new Quality Risk Management Process into global QMS
- Improve global QMS by creation of a harmonized quality compliance file process over EMEA sites of the Company who working with CMOs and build a new global regulatory compliance team over different EMEA sites accordingly and lead the team
- Implement Project Management Tools into the global CMO Quality Management System to drive QA process more structured and efficient
- Manage quality related projects until the product enters commercial phase or legacy products for technology transfers
Jan 2017 - Dec 2020
4 yearsDarmstadt, Germany
Director, Head of Quality Assurance Chemical and Pharmaceutical Development
Merck Healthcare KGaA
- Improve QMS by adaption into the pharmaceutical development processes of qualification of CDMOs, Development of Analytical Methods, Development of Manufacturing Processes, Manufacturing of Investigational Medicinal Products and Clinical Trials Supply
- Quality system reviews, maintenance/analysis of KPI’s Lead Times of Deviations, Investigations, CAPAs, Change Implementation, Supplier/CMO Qualification and efficiency of Audits by health authorities, Quality Alerts
- Improvement of application of quality by design approach during pharmaceutical development by linking process and material impact to the efficiency and safety of medicinal products with risk management tools
- Developing and Leading of Qualified Persons, Quality Manager and Quality Technicians with independent development plans for their soft and hard-skills
- Global QMS Harmonization Program between manufacturing sites in Germany, Italy and France
- Direct management of inspections/audits conducted by health authorities, global and corporate quality units
- Maintain the systems required for the efficient and effective QP assessment and disposition of investigational medicinal products
- Assure that vendors are acceptable for the intended purpose and audited at defined frequencies
- Member of the development site leadership team
- Responsible for staff in the QA organization 20 directs
- Financial accountability for the quality budget
- Executed Change Management project for a new organizational set up in the Quality Assurance organization (2018).
- Led QMS Improvement for the preparation of an FDA Pre-Approval Inspection for a new formulated product (2017).
Jan 2014 - Dec 2017
4 yearsDarmstadt, Germany
Associate Director, Head of Validation / Qualification and Engineering
Merck Healthcare KGaA
- Lead and develop a team of senior Managers for CSV, Process and Cleaning Validation and Equipment Qualification
- Improvement of the local Quality Management System by integration of a new FDA Process Validation approach into the QMS (also as a specific QMS improvement project in 2016 establishing new process validation process acc. FDA Guidance).
- Improvement of the local Quality Management System by integration of a new Lifecycle related Cleaning Validation Process into the QMS (including implementing Permitted Daily Exposure Limits for Cleaning Validation Process in 2016).
- Improvement of the local Quality Management System by integration of a new periodic review process for validated process/legacy products.
- Implement a new IT-System for the semi-automated continued process verification and the computerized system validation of the IT-System
- Establish and update of quality standards and implementation global quality standards for Computerized System Validation, Process Validation, Cleaning Validation and Engineering-Equipment Qualification
- Leading a preparation project for a PAI acc. CAPA plan to eliminate GAPS in the QMS – Development, Transfer and Validation
- Assessment of the GMP compliance for CSV, Process and Cleaning Validation, Equipment Qualification and Engineering activities in the solid, liquid and packaging plants on site
- Quality assurance of process validation activities during site to site and CMO product transfers
- Support of new product launches
- Supplier audits as GMP auditor
- Management of inspections/audits conducted by health authorities, global and corporate quality units
- Led QMS Improvement (Lean Six Sigma) project for optimization of the technical change management process (2015).
Jan 2011 - Dec 2014
4 yearsMannheim, Germany
Quality Manager, Deputy Head of Quality Planning & Validation
Roche Diagnostics GmbH / Roche Diabetes Care AG
- Execution of Computerized System Validation and Process Validation projects for manufacturing of insulin pumps
- Project Leader for the qualification of new manufacturing lines for insulin pump systems (2012).
- Equipment management for test- and operating materials, equipment and IT-Systems
- Transfer of a manufacturing site from Switzerland to Germany – process owner for process validation and equipment management
- Lead of external consultants in validation projects
- Deputy head of the team’s: process validation, quality planning and risk management
Jan 2011 - Dec 2011
1 yearWeiterstadt, Germany
Head of Validation
Warner Chilcott Deutschland GmbH
- Leading a Team of 12 direct reports (experts) and execution of Computerized System Validation, Cleaning Validation, Equipment Qualification and Calibration of the facility and systems within operation
- Responsible for internal and external audits
- Cooperate in global cross functional validation teams
- Financial accountability for the validation budget
Jan 2010 - Dec 2011
2 yearsLudwigshafen, Germany
Senior Project Engineer
M+W Process Industries GmbH
- Lead cleaning validation projects in biopharmaceutical industry
- Business development – Establishing a new cleaning validation service for the pharmaceutical industry (Project Leader for the development of a new service provider unit for Cleaning Validation, 2011).
- Cooperate with global cross functional and cultural engineering and validation teams – Building of a new manufacturing site for vaccines (Sub-Project Leader for the cleaning validation of a new manufacturing plant for vaccines, 2010).
Jan 2007 - Dec 2010
4 yearsIngelheim am Rhein, Germany
Validation Engineer
Boehringer Ingelheim Pharma GmbH & Co. KG
- Validation of the cleaning and transport processes at the manufacturing site in Ingelheim for solid products
- Develop new cleaning processes and transfer to commercial manufacturing area (Project Leader for the development of a new cleaning process for a new dosage form, 2007).
- Develop shipment simulations (cycling studies) for transport validation projects
- Support manufacturing of IMPs for clinical studies and launch of new products
- Technology/process transfer from site to site (Sub-Project Leader for a site to site technology transfer of a pellet manufacturing process, 2008).
Summary
Experienced quality leader with 17 years of professional experience in the pharmaceutical and medical device industries. Lead various projects and teams with increasing responsibility. Deep end-to-end knowledge in processes and the regulatory requirements from development to commercialization of pharmaceuticals and Medical Devices. Experience in building and restructuring organizations. Freelance lecturer at TÜV Süd Academy and international events and congresses
Languages
German
NativeEnglish
AdvancedTurkish
Advanced Education
Oct 2020 - Present
Medical Faculty Mannheim, Heidelberg University
Human Medicine · Mannheim, Germany
Oct 2003 - Jun 2007
University of Albstadt-Sigmaringen
Graduate Engineer Pharmaceutical Engineering · Pharmaceutical Engineering · Sigmaringen, Germany
Oct 1999 - Jun 2002
University of Furtwangen
Medical Engineering · Furtwangen, Germany
Need a freelancer? Find your match in seconds.
Try FRATCH GPT More actions
Similar Freelancers
Discover other experts with similar qualifications and experience
