2. SUNANDO BASU
M.Pharm (Quality Assurance),RQAP-GLP, MRQA
Qualified QA Auditor (ISO 19011:2002)
Trained in GLP from WHO-TDR, BARQA (UK)
Trained in GCP and UK Clinical Trials from BARQA (UK)
Benchmarked ICH-GCP from Infonetica Ltd
Familiar with ISO-9001:2008 revision
14 Years of Experience in Quality Assurance (GLP plus GCP)
Added Capabilities: GMP, ISO 9001:2008, ISO 17025, ISO 15189 knowledgeable
Way to My Professional Life
3. 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
Core Competencies
4. 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)
Skills
5. First Association with…
TORRENT RESEARCH CENTRE of TORRENT PHARMACEUTICAL LTD
From- 2001 to 2005
Achievements:
After Completion of Post Graduation M. Pharm specialization QUALITY ASSURANCE…
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
Structured many In-House Training Program and Workshops
Established OECD GLP components
Identified and implemented more than 500 Standard Operating Procedure
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
Established ICH Good Clinical Practice (GCP) requirements
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
Managed a group of 8 QA professional
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
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…
KRISH BIOTECH RESEARCH PVT LTD (CRO offering Pre-clinical and Analytical Chemistry
Services)
From- October’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
Archive 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
9.
10. Continuous Learning/Benchmarking activities
Diploma in Pharmaceutical Marketing Management from Institute Of Pharmaceutical Education and Research,
Pune, India .
Demonstrated the knowledge on The Principles of Good Laboratory Practice for Professional Auditor conducted
by British Association of Research Quality Assurance (BARQA)-United Kingdom.
Accomplished the distance learning course on Decision Points in Drug Development sponsored by Pharmaceutical
Education and Research Institute, Inc (PERI)-USA .
ISO 19011:2002 (Quality and/or Environmental Management Systems Auditing) exam conducted by British
Association of Research Quality Assurance (BARQA)-United Kingdom .
Participated in USFDA’s course on “Drug Review and Related Activities in the United States” scoring 89.47 %.
August’1996
August 19th, 2005
October 28th, 2005
November 4th, 2005
11. Continuous Learning/Benchmarking activities
Passed Inspector Self-Study: eLearning, sponsored by The College of American Pathologists ,USA.
Benchmarked ICH−Good Clinical Practice knowledge from Infonetica Ltd endorsed by Royal Holloway, University
of London .
Passed Open Access GCP Test from Pharmaschool -UK .
March 12th, 2006
August 7th, 2010
August 10th, 2010
Earned the Registered Quality Assurance Professional designation in Good Laboratory Practice from Society of
Quality Assurance (SQA)-USA
Trained in ICH-GCP from British Association of Research Quality Assurance (BARQA)-United Kingdom .
E-Trained UK Clinical Trial Regulation from British Association of Research Quality Assurance (BARQA)-United
Kingdom .
Awareness on ISO-9001:2008 Changes; Institute of Sigma Learning Pvt Ltd, India
October’2010
November’2010
November’2010
Janaury’2011
12. Poster presentation titled “Performance Measurement of the Documentation
Practice in a Non-Regulated Research Area” at BARQA (British Association of
Research Quality Assurance) 2009 Annual Conference – Brighton.
Was judged Third Best by BARQA’s Publication Committee (British Association of
Research Quality Assurance), United Kingdom for the Article titled “QA Professional:
Attributes and Roles”.
28th October 2009
December’2009
International and National Contribution So Far…
13. Poster presentation titled “ Team Excellence: An Important Factor That Contributes To
Quality Culture ” at BARQA (British Association of Research Quality Assurance) 2010
Annual Conference – Leeds.
Awarded with First Prize by BARQA’s Publication Committee (British Association of
Research Quality Assurance), United Kingdom for the article titled “Horoscope: QA
Professional”
2nd - 5th November 2010
December’2010
International and National Contribution So Far…
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)
Good Laboratory Practice Requirements and How to Comply
Good Laboratory Practice for Study Personnel
Proficiency Testing as per ISO 17025
Equipment Qualification
Records and Recording
SOP-An Effective Communication Tool
Structuring QA in Non-regulated Early Research
Computerized System Compliance-A must to do
Raw Data Documentation
