Amit Mondal

A dynamic professional with 27 + years of experience in API and Finished dosage form (Sterile and Non-Sterile); spreading into Quality Operation (QA and QC), Regulatory Affairs and Manufacturing Operation. Experienced in establishing Quality Management Systems, Quality Assurance and Regulatory Compliance in the field of sterile and non-sterile drug substances and drug products manufacturing sector. It includes creation and implementation of Quality and Regulatory policy, preparation for FDA, EU and other International regulatory authority inspections. It also encompasses the experience in qualification of manufacturing equipment, plant utilities, equipment cleaning and manufacturing processes (sterile and non-sterile, SVP and OSD). Experience also counts the responses to various regulatory agencies observations for example FDA 483s, Non-Conformance and Warning Letters. Out of 27+ years, 17+ years in API industry and 10 years in finished dosage form. Talented Vice President with excellent employee development, customer service and analytics skills coupled with more than 27 years of experience. Comfortable giving engaging presentations to clients to drive new business, expand accounts and establish brand profile. Excellent team builder and leader of initiatives. Accomplished 27 with progressive industry background and decisive leadership style. Offers strategic planning abilities, background in change management and forward-thinking mindset. Ready for challenges and focused on meeting future demands. Performance-driven Vice President with 27 years of experience aligning systems with business requirements, policies, and regulatory requirements. Passionate about applying excellent organization and communication skills to manage and lead teams. Results-oriented individual well-versed in interfacing and consulting on business processes to drive results based on sound overall business judgment. Results-driven Vice President with forward-thinking approach centered on company success and competitive growth. Demonstrated record of success in building successful teams and managing profitable operations. Pragmatic professional with solid experience in leadership roles. Adept at implementing strategic business plans, driving growth and improving operations. Skilled in financial management and stakeholder relations. Collaborative and dedicated to building and leading talented and motivated individuals. Persistent leader eager to lead and grow organizations. Skilled in strategic planning, problem-solving, and communication with good understanding of business principles, project management and team leadership. Collaborative with relentless work ethic. Dynamic individual with hands-on experience in Quality and Operation and talent for navigating challenges. Brings strong problem-solving skills and proactive approach to new tasks. Known for adaptability, creativity, and results-oriented mindset. Committed to making meaningful contributions and advancing organizational goals.

Loves to read book, be it biography, novel, thrillers or comics