- 1. ALL YOU WANT TO ABOUT ME(In Brief)
2. Way to My Professional Life
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
Document/Database Compliance Assessor
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
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
Established ICH Good Clinical Practice (GCP) requirements
Conducted morethan 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- Jan2006 to Aug2006
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- Sep2006 to May 2011
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- June2011 to till date
Quality Management System establishment
Supervision of QA programs andday to day activities
Audit Managementincluding Third Party and Vendor Audit
Training and mentoring of staff on various GXP topics
GLP consultancy to project team
Hosting and communicatingwith Client and RegulatoryAgencies
Leading, and motivating cross functional employees to ensure GLP compliance
9. MISCELLANEOUSACHIEVEMENTS OF MINE.
10. Continuous Learning/Benchmarking activities
August 19th, 2005
October 28th, 2005
November 4th, 2005
11. Continuous Learning/Benchmarking activities
March 12th, 2006
August 7th, 2010
August 10th, 2010
12. International and National Contribution So Far
28th October 2009
13. International and National Contribution So Far
2nd - 5th November 2010
Addressed the topic GLP-Documentation at Indian Pharmaceutical Association Auditorium, Kolkata, India
14. Subjects that I have acted as a Mentor (In-House)
Plus the INDUCTION TRAINING SPECIALIST
15. Professional Association
16. For More information look into my CV