Esra K.

Background

About Esra K.

A dedicated and motivated Pharmaceutical Professional with over a decade of experience in the regulated industry, including sterile pharmaceuticals manufacturing, contract research laboratories, QC/AR & D labs, and QA/IT Compliance. Possesses deep knowledge of laboratory instrumentation and Data Integrity principles, specializing in computerized system validation and e-data security and integrity for the last seven years. Demonstrates expertise in software and computer system validation in compliance with 21 CFR Part 11, CSA, Data Integrity, and GxP FDA Regulations, with proficiency in change management, incident management, and data archival. Experienced in various validation methodologies, including Risk-based (GAMP 5), Agile, and V-model, applied to diverse applications such as COTS, SaaS, and custom-developed systems. Skilled in authoring and reviewing comprehensive validation documentation, with extensive knowledge of global regulatory guidelines. Proficient in industry-standard applications and adept with test and project management tools, excelling in Good Documentation Practices to ensure compliance and integrity across all processes.