Dynamic Quality Assurance professional with over 20 years of experience in the pharmaceutical industry, including a decade in core QA leadership with a strong emphasis on technical training and compliance oversight. Expertise in implementing Quality Management Systems (QMS), ensuring regulatory compliance, and conducting thorough audits and validations, all while maintaining meticulous documentation. Skilled in driving audit readiness, managing Corrective and Preventive Actions (CAPA), and fostering a culture of continuous improvement through targeted training initiatives. Proven ability to lead teams in achieving organizational objectives by employing strategic planning, effective communication, and conflict resolution techniques that promote a cohesive and productive work environment.
TrackWise Documentum JMP SAP MES Minitab LMS (Success Factor, Nichelon5-CMS) Qase JIRA MS Office 2023
Strong QA leadership with compliance-first mindset
Skilled in audit readiness and regulatory interaction
Effective communicator and cross-functional collaborator
Strategic trainer who uses learning as a compliance tool
Quality Assurance & Compliance: QMS implementation, GxP compliance, internal audits, CAPA, change control, incident management, Site Quality Review Program
Regulatory Readiness: Audit exposure to USFDA, MHRA, ANVISA, ANSM, EMA / EU, WHO, DGCI, customer & vendor audits
Validation & Documentation: Computer system validation, batch record review, analytical work record review, SOP preparation & approval, Artificial Intelligence Management System
Risk & Gap Assessment: System-level audits (6-system approach), gap analysis, audit preparedness
Training as QA Enabler: Designing and delivering GxP training, LMS administration, trainer qualification programs to ensure compliance culture