Omer Cimen work email
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Omer Cimen personal email
With 17 years of experience in Pharma, I led numerous high-impact projects for global pharmaceutical and healthcare clients such as Novartis, Mundipharma, Sandoz and others. My experience spans across SAP and S4HANA implementations, where I played critical roles, from Project Quality Manager to Validation Lead. I managed rollouts in diverse locations, including the UK, Turkey, Japan, India, Poland, North Macedonia, Bangladesh, Egypt, Germany, Austria, Slovenia and Switzerland, ensuring compliance with GMP, GAMP, and 21 CFR Part 11. My expertise includes risk assessments, project management, and software/system validation life cycle management. Now, I am the founder of Validfor, a cutting-edge software validation life cycle management solution. At Validfor, we aim to streamline and enhance the software validation process for companies, helping them achieve compliance and operational excellence. I am passionate about leveraging my experience to deliver innovative and efficient solutions that drive business growth and digital transformation.
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Co-Founder And CeoValidforEstonia -
FounderValidfor Oct 2024 - Present -
Programme Validation Stream LeadMundipharma Mar 2021 - Sep 2024United KingdomDelivered agile validation support across diverse systems, including equipment, computerized systems, in a complex, multi-disciplinary validation program. Enhanced project agility and streamlined processes through continuous quality monitoring. -
Head Of Business DevelopmentConval Group Nov 2007 - Sep 2024Istanbul, TurkeyDuring my 17-year tenure at Conval, I played a key role in driving the company’s growth through various complex and large-scale projects. I specialized in developing comprehensive validation strategies tailored to customer needs and led a team that managed over 20+ major and 90+ small/medium-sized projects. My responsibilities included mentoring junior consultants, managing customer success, and spearheading digital transformation efforts. Additionally, I established and expanded the digital services department, significantly enhancing Conval's capability to deliver efficient and innovative solutions. -
Programme Quality ManagerNovartis Dec 2017 - Aug 2021SwitzerlandDirected validation strategy across multiple streams for an extensive program initiative. Applied agile methodologies to coordinate validation efforts across systems, ensuring consistent compliance with quality and regulatory requirements. -
Programme Quality ManagerNovartis Oct 2015 - Dec 2017SloveniaLed quality management for a project to enhance and rebuild advanced planning processes. Ensured compliance and validation throughout the transformation, optimizing planning workflows for efficiency and alignment with quality standards. -
Project Quality ManagerNovartis Jan 2015 - Aug 2015SwitzerlandProvided quality assurance and validation support for the SAP system, specializing in CSV processes to ensure robust compliance and seamless project alignment across cross-functional teams. -
Project Quality ManagerNovartis Aug 2014 - May 2015AustriaLed quality management and validation for a greenfield ERP implementation at a new manufacturing facility. Established comprehensive validation protocols to ensure quality and regulatory compliance from project initiation to operational readiness. -
Project Quality ManagerNovartis Sep 2013 - Jun 2014JapanPioneered a paperless testing framework for validation, later adopted by the client as an internal standard for efficiency and compliance. Championed digital transformation in quality processes, achieving substantial improvements in validation speed and accuracy. -
Project Quality ManagerSandoz Feb 2013 - Sep 2013GermanyCollaborated with global teams to lead Computerized System Validation (CSV) initiatives. Focused on maintaining compliance across CSV projects within a structured quality framework. -
Project Quality ManagerSandoz Jul 2012 - Feb 2013EgyptEngineered innovative solutions to overcome project challenges in emerging markets. Spearheaded digital approval workflows to streamline project processes. -
Project Quality ManagerSandoz Feb 2012 - Jul 2012BangladeshDeveloped and adapted validation methodologies for geographically dispersed teams, facilitating collaboration across multiple locations. Implemented hybrid solutions for cohesive project execution. -
Project Quality ManagerTurkish Airlines Mar 2011 - Oct 2012TürkiyeOversaw SAP implementation within the aviation sector, emphasizing quality controls and project methodology. Maintained high standards of project governance and validation integrity. -
Project Quality ManagerLek Pharmaceuticals Oct 2011 - Feb 2012North MacedoniaLed quality assurance for an ERP validation project, serving as the hub for multiple nearby countries. Managed cross-border compliance, ensuring the project's adherence to quality standards and harmonized procedures across regional hubs. -
Validation ConsultantSandoz Apr 2010 - Feb 2011IndiaDirected the validation process for ERP deployment across three manufacturing sites. Coordinated cross-functional teams to manage change control, test execution, and deviation resolution for comprehensive ERP coverage. -
Validation ConsultantSandoz Apr 2009 - Feb 2010GermanyProvided validation expertise for SAP implementation. Specialized in risk assessment, change management, and test validation for enhanced system reliability. -
Validation ConsultantLek Pharmaceuticals Jul 2008 - Feb 2009PolandExecuted validation activities for a full-scale ERP deployment, addressing requirements across multi-site manufacturing facilities. Focused on change management and testing to ensure compliance and seamless operational integration. -
Validation ConsultantSandoz Nov 2007 - Jul 2008TürkiyeERP implementation validation for manufacturing, quality, and supply chain functions across two manufacturing sites. Oversaw all aspects of validation, including change management, test case development, and deviation handling.
Omer Cimen Education Details
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Industrial Engineer
Frequently Asked Questions about Omer Cimen
What company does Omer Cimen work for?
Omer Cimen works for Validfor
What is Omer Cimen's role at the current company?
Omer Cimen's current role is Co-Founder and CEO.
What is Omer Cimen's email address?
Omer Cimen's email address is om****@****for.com
What schools did Omer Cimen attend?
Omer Cimen attended Istanbul University.
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Dr. Ömer Çimen
Istanbul, Türkiye -
1hotmail.com
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