I am expertise in the field of Analytical Laboratory management and has faced several Regulatory audits in various Industries and as part of the leadership team. I had worked with big Companies in various segments like APIs, Pharma Intermediates, Crop projects Intermediates, Specialty fine chemicals, CDMO / CRO (for new candidate drugs), FTE R&D services and Agrochemicals etc. My specialty includes Analytical method development, method validation and it’s transfer to QC lab, stability testing as per ICH guideline, cGMP Testing and Release for APIs & Drug Product’s, to resolve regulatory queries related to DMF and implementing and maintaining GLP & Regulatory requirement in the Analytical division. Possesses a sound practical knowledge, complete understanding of “Data Integrity”, and its importance in cGMP Analytical laboratories. I am expert in setting up the Analytical R&D lab, team mentoring and successful delivery projects. Specialties: Analytical Lab management (GLP), Dexterous in managing and retrieving analytical data with strong documentation system. Capable of changing mindsets and set practices to comply with regulatory requirements, Data compilation.Skill Set • Well-developed commercial acumen and solution-oriented approach with decision making abilities to achieve the organization’s objectives • Assertive with a strong results orientation, “ can do ” attitude and a sense of urgency to get things done and forge healthy relationships. • Demonstrated ability to multi-task and thrive in a dynamic, fast-paced environment. • High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction. • Can collaborate across multiple cross-border groups and be comfortable in a matrix reporting structure. • Have focus on quality and excellence and strong analytical intuition; be sharp in identifying problems and solutions. • Have disciplined approach and agility to effectively build on the ideas and navigate difficult conversations to maximize adoption of strategic initiatives. • Ability to positively influence and strong interpersonal, including a high level of personal impact and approachable style. • Well-developed communication skills and excellent articulation skills • Strong people leadership skills, ability to lead large teams using situational leadership styles and create a high performance culture.