Pharmaceutical professional, experienced in regulatory pharmaceuticals and actively engaged in quality culture development. Expertise in: 1. EQMS / EHS/ PLM software implementation. -Implemented Trackwise Digital (TWD), Caliber QAMS and ComplianceQuest (CQ) Solution 2. Computerized system administration, configuration and maintenance inline with 21CFR Part 11, Annex 11. 3. Walkthrough & Gap assessment 4. Global CAPA & Investigation management 5. Compliance and inspection readiness 6. Computirized System Validation and Computer Systems Assurance Program. 7. Proficient in Batch release (QP) for sale and distribution for US, EU and other international markets. well versed in: 1. Change control 2. ALCOA and data reliability 3. Training and Core documentation activities of QA department. 4. 7-step approach of CAPA, SCAMPER, DMAIC, 8D, Problem Solving. Audit faced: USFDA, MHRA, Anvisa, Ukraine.