3. Core Competencies Quality System Engineering Specialist Quality Assurance and Regulatory Compliance Analyst Statistical and Risk Based Audit and Inspection Expert Standard Operating Procedure (SOP) Management Advisor Training/Mentoring Instructor Document/Database Compliance Assessor Instrument/Equipment qualification/validation Regulatory Advisor Regulatory and Client Inspection hosting expert People Management acquainted Drug Development (Preclinical to clinical Stage) knowledgeable Certified GLP (Good Laboratory Practices) and GCP (Good Clinical Practices) Professional
4. Skills Problem solving Capable of analyzing and debating complex issues Superb organization, communication and presentation skills Possess strong leadership and people management skills Capable of dealing effectively within cross-disciplinary teams and with vendors Strong knowledge of quality assurance processes and procedures IT Skills: MS application (word-processing, spreadsheet, and database)
5. After Completion of Post Graduation M. Pharm specialization QUALITY ASSURANCE… First Association with… TORRENT RESEARCH CENTRE of TORRENT PHARMACEUTICAL LTD From- 2001 to 2005 Achievements: Established OECD’s GLP components Established ICH Good Clinical Practice (GCP) requirements Conducted more than 100 statistical based preclinical Study Audit, more than 50 BA/BE studies, critical Process Audit and Facility Audit including computerized audit as QA Auditor Identified and implemented more than 500 Standard Operating Procedure Structured many In-House Training Program and Workshops Performed the role of a Regulatory Advisor, towards Contemporary Drug Development Process of the New Chemical Entities, and on IND (Investigational New Drug Application) filing to project team in the internal meeting providing compliance advice and guidance Hosted Regulatory Inspection successfully
6. Second Association with… ACCUTEST RESEARCH LABORATORIES LTD (Clinical Service Contract Research Organization) From- Jan’2006 to Aug’2006 Achievements: Established Quality System as per the ICH Good Clinical Practice (GCP) regulations for various regulatory bodies through the preparation of Quality Policies As a Manager, handled Audit and Inspection mainly scheduling, resourcing and allocation Responsible for generating and providing status and trend reports to the management, identification of quality risks and risk prevention strategies, ensuring Corrective and Preventative Action (CAPA) plans are generated and closed and documented and that the Quality Documents remains compliant with all applicable laws and regulations Managed a group of 8 QA professional Performed the role of the Mentor to train staff on GXP issues Hosted client and regulatory inspections
7. Third Association with… TCG LIFESCIENCES LTD , CHEMBIOTEK (Discovery Research Services Company) From- Sep’2006 to May’ 2011 Achievements: Principal in developing and implementation of the following quality components: Standard Operating Procedures management system. Good Documentation Practice and Document control. Induction training Program. Concept of Staff Records Management. Instrument/Equipment Management Application system. Inventory Management System. Laboratory monitoring procedure across the different departments. Safety and Waste Management system. System of Good Archival Practice. As a manager, responsible for day to day QA activities
8. Present Association with… VIVOBIO (Pre-clinical Research Services Company) From- June’2011 to till date… Responsibilities: Quality Management System establishment Supervision of QA programs and day to day activities Audit Management including Third Party and Vendor Audit SOP Management Document Management Training and mentoring of staff on various GXP topics GLP consultancy to project team Hosting and communicating with Client and Regulatory Agencies Leading, and motivating cross functional employees to ensure GLP compliance
13. International and National Contribution So Far… 2nd - 5th November 2010 December’2010 Addressed the topic “GLP-Documentation” at Indian Pharmaceutical Association Auditorium, Kolkata, India December’2010
14. Subjects that I have acted as a Mentor (In-House) Plus the INDUCTION TRAINING SPECIALIST
