·   investigations, and all-time readiness of sites for regulatory agency audits. ·   Demonstrated experience in Quality systems design and continual improvement in Quality Compliance in green/brown field formulations and API projects and commercial manufacturing sites. ·   Proven Excellence in developing quality culture and people first approach. ·   Dynamically spearheaded the Quality Teams and setting priorities for people development and improving competence of workforce. ·   Adroit in facing regulatory agency audits, customer audits, market complaints and customer queries. Faced all major regulatory agency audits in Formulations (OSD and injectables (sterile) dosage forms)·   Expertise in ongoing quest for innovations, automations, and linking it with improved quality compliance and revenue of organization. ·   Diligently oversaw the quality processes and quality related issues decision making. ·   Robust experience in dispensing cost-effective Quality initiatives and monitoring its effectiveness to fulfill both compliance and budget demands. ·   An effective communicator with excellent presentation, interpersonal, analytical, problem solving and leadership skills.