ALL YOU WANT TO ABOUT ME… (In Brief)

SUNANDO BASUM.Pharm (Quality Assurance),RQAP-GLP, MRQA, MICR

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

10 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

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

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

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’s 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

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

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

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

MISCELLANEOUS ACHIEVEMENTS OF MINE….

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

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

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…

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

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

Plus the INDUCTION TRAINING SPECIALIST

Professional AssociationMember-MRQA Active member

Professional Member-MICR Life Member

For More information look into my CV…