Tekirdağ, Türkiye
As a Senior Analyst at Accenture, I specialize in pharmaceutical manufacturing execution systems (MES) validating solutions that meet the stringent demands of regulated environments. Holding a master’s degree in pharmacy, I bring both deep domain expertise in pharmaceutical sciences and strong technical skills in manufacturing systems. This unique combination allows me to bridge the gap between shop-floor operations, regulatory compliance, and digital innovation. My expertise spans: *Validation & Compliance – delivering fully validated systems aligned with industry regulations and quality standards *Process Optimization – improving production workflows and data integrity across the manufacturing lifecycle Passionate about leveraging technology to drive quality, compliance and innovation, I help life sciences organizations accelerate time-to-market while ensuring patient safety. 📌 Always eager to connect with professionals in pharma tech, MES, Industry 4.0, and supply chain innovation.
Specializing in pharmaceutical manufacturing execution systems (MES), I focus on validating MES solutions tailored for highly regulated pharmaceutical manufacturing environments. I ensure that all systems comply with GxP regulations, FDA guidelines, and industry best practices. My role involves collaborating closely with cross-functional teams—including quality assurance, IT, and manufacturing operations—to optimize production workflows, maintain data integrity, and support regulatory audit readiness. This role leverages my combined expertise in pharmacy and technology to enhance operational efficiency, quality, and compliance in pharmaceutical manufacturing.
• Conducted computerized systems validation in compliance with 21CFR P11 requirements and MHRA guidelines. • Managed V-cycle processes, system categorization, and prioritization using Gamp categories. • Implemented challenge tests to ensure system functionality and integrity.
Qualification and Validation project of Laboratory and Production Equipment
Today, the increasing popularity of recombinant technologies, Turkey has begun to enter the market in the pharmaceutical industry. As a resulty of this; an area is also opened for the adaptation of the Validation requirements to Biotechnological Processes. As a bioengineer who has full knowledge of all components of biotechnological processes, I learned the requirements for validation as a part of Conval Group with in-house trainings and knowledge transfer, and worked on the fulfillment of validation requirements in the biotech pharmaceutical industry.