Katarzyna Pluta

WORK HISTORY

EDUCATION

SKILLS

ABOUT KATARZYNA PLUTA

Who I AmI am a versatile scientist with over 10 years of hands-on experience in computerised systems, laboratory science, and quality assurance, gained across diverse environments in Europe and Africa. My background spans university research, the pharmaceutical industry, clinical diagnostics, and the medical devices sector, with a strong foundation in both technical laboratory methods and regulated quality systems.Currently, I work as a Computer Systems Validation (CSV) and Data Integrity Engineer within a medical devices company supplying major biopharmaceutical organizations. In this role, I play a key part in shaping and strengthening the data integrity framework, ensuring GxP computerised systems meet regulatory expectations and support reliable, high-quality data across the product lifecycle. I provide global compliance and validation oversight, helping bridge operational needs with regulatory requirements in a highly regulated environment.I bring a proactive, solutions-oriented mindset and thrive in fast-paced, cross-functional settings. I am known for my ability to adapt quickly, manage multiple priorities, and deliver with precision—whether training teams, leading validation activities, conducting investigations, analyzing complex datasets, or supporting regulatory inspections. I am equally comfortable presenting findings, leading initiatives, and working in full compliance with GMP, GLP, and international standards.My GoalMy goal is to build and continuously enhance a robust, scalable data integrity framework that ensures data is accurate, reliable, and inspection-ready across all GxP systems. I aim to drive a culture of compliance and accountability by integrating data integrity principles into everyday operations, supporting both regulatory excellence and business performance.I am particularly motivated to contribute to organizations where I can combine my expertise in Computer Systems Validation (CSV), quality systems, and data governance to strengthen processes, mitigate risk, and enable confident decision-making through trusted data.Volunteer & Personal InitiativesOutside of work, I actively volunteer with charitable organizations focused on children’s welfare and animal care. I also enjoy supporting friends and small businesses with website development, marketing strategy, and organizational planning—applying the same structured, analytical thinking I use in my professional life.Contact: k••••••••@gmail.com