Rich experience of over 2 decades within pharmaceutical domain. Familiar with various manufacturing processes, process validation and documentation system. Manages the company’s compliance with state and federal aggregate laws with proactive involvements in system framing and evaluation, businessre view and risk mitigation

Sound exposure of cGMP, USFDA, MCA, GHA, TGA, WHO and EU/EDQM related documentation and audits. Has faced 70+ customer and 15+regulatory audits. Independently conducted 35+ vendor audit (India & Overseas)

Ensures the provision of a comprehensively designed and effectively implemented system of Quality Assurance incorporating best manufacturing practices and compliance management

Interfaces with regulatory bodies as necessary to demonstrate quality system compliance in support of certification/recertification activities for Indian and global markets