Sei sulla pagina 1di 7

SUNANDO BASU

M.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

EXPERIENCE AND SKILLS (Quality Assurance And Regulatory Affairs)

Quality Assurance Professional with 9 + years of mixed experience in the field


of:
-Good Laboratory Practice (GLP) as per OECD GLP and USFDA's 21 CFR Part-58
-Good Clinical Practice (GCP)

Actively involved in providing leadership as a Quality Manager, majorly contr


ibuting to:
Quality Management activities (GLP/GCP related)
Mentoring and Coaching activities
Regulatory and Client Pre-Inspection activities
People Management activities
Solution Provider
System Development activities

As functional responsibility, performed the role of a QA Auditor. Mainly invo


lved in planning and conducting Statistical Based Study Audit, assessing the pre
clinical (Regulatory Toxicology, Safety Pharmacology, Analytical Method Validati
on) and clinical Study (BA/BE) that compromises:
Protocol review for regulatory compliance, Raw data validity, Data entry accurac
y and completeness, Data analysis validity, Study report accuracy and completene
ss

Conducted In-phase assessment of different Processes related to preclinical an


d clinical study that includes:
For Preclinical Study- Test Article Characterization And Stability, Acclimatizat
ion, Animal Housing, Dosing, Weighing, Clinical Sign Observation, Necropsy, His
topathology etc
For Clinical Study- Drug Accountability, Subject Recruitment And Informed Consen
t, Pathology, Phlebotomy, Subject Care, Biological Sample Processing, Biological
Sample Analysis etc

Performed System Audit, assessing and providing guidance on continuous improve


ment and thus verifying the implementation of the Corrective Actions.
The systems include:

GLP related: HVAC system, Water system, Cage washing controls, Animal feed contr
ols, Personnel training, Environmental monitoring, Instrument/Equipment qualific
ation including Computerized System, Archive etc
GCP related: Clinical & pathological unit maintenance, vendors, Personnel traini
ng, Environmental monitoring, Instrument/Equipment qualification including Compu
terized System, Archive etc

Actively participated in the System Review Meeting, reporting the compliance a


ssessments of all audits and inspections to the management and where necessary p
rovided guidance on further quality improvement.

Involved in identifying, planning and conducting Training Program, acted mainl


y as a Mentor/Coach.

Involved in identifying, reviewing, approving, implementing Standard Operating


Procedure. Also acted as an SOP Administrator.

Additionally, played a part as a Regulatory Advisor, for New Chemical Entities


, and on IND filing in internal meeting.

Conducted Pre-Inspection preparation, ensuring that the organizational process


es and procedure are in compliance with local and international regulatory requi
rement and that the personnel are trained to face the audit. Additionally, acted
as a point of contact between the management and with the inspector/client.

Have 4 years of experience in People Management through building and maintaini


ng beneficial working relationships with all internal and external customers. Ma
naged a group of 8 QA professional.

Instrumental in Development and Implementation of the Quality System for:


BA/ BE study site for various regulatory bodies like ANVISA, DCGI, USFDA and M
HRA
Investigational Products manufacturing for GMP compliance to be used in clinic
al trials
Animal Facility in accordance with "Guide for the Care and Use of Laboratory A
nimals"
Non-regulated research area in a contract research organization
EMPLOYMENT HISTORY

From September 2006 to present


Position : Manager-Quality Assurance
Company : TCG Life Sciences Ltd (Discovery Research Services Company)
Job Profile : Leadership Role for implementation and overseeing quality system
Instrumental in Development and Implementation of some of the GLP Quality System
:
Standard Operating Procedures (SOPs) concept
Document management and Good Documentation Practice concept
Induction training Program and On-the-Job training
Instrument/Equipment Qualification and Maintenance Management concept
Inventory Management compromising from purchase, receipt, storage, issue, and
distribution of consumable material and test item/substance
Laboratory monitoring management
Management of Good Archival Practice
Safety and Waste Management
Moreover, involved in audit and inspection (Facility related), mentoring and coa
ching to the scientific staff on various GXP topics, practices and support activ
ities linked to coordination and hosting client inspection

From January 2006to August 2006


Position : Manager/Head-Quality Assurance
Company : Accutest Research Laboratories Pvt. Ltd
(Full Service Clinical Contract Research Organization-CRO)
Job Profile : Managerial as well as Functional activities
Listed are some major responsibilities but not limited to:
Overseeing the Quality Assurance (QA) function towards BA/BE studies that incl
ude:
* Clinical phase
* Pathology Unit (*Instrumental in developing the unit as per ISO 15189 and sel
f learned the requirement through e-training from The College of American Pathol
ogists, US)
* Bioanalytical phase
* Statistical phase
Managing the audit schedule resourcing, allocation and performing.
Ensuring through coaching that the skills' pools in the Audit teams are proper
ly trained.
Responsible to lead, motivate and influence cross functional employees (Clinic
al Pharmacological Unit, Pathology Unit, Bioanalytical Unit, Data Processing Uni
t) to ensure GCP and GLP compliance.
Ensuring that the Corrective and Preventative Action (CAPA) plans are generate
d, closed and documented.
Providing training to educate and guide staff on various compliance issues/pra
ctices and interpretation of regulations.
Acted as solution partner- helping to find solutions to quality & compliance i
ssues.
Involved in reviewing documentation, processes and procedures as they relate t
o:
* IRB
* Essential documents
* Source data verification
* Protocol violation and study conduct
Responsible for coordination and hosting client inspection

From 2001 to December 2005


Position : Quality Assurance Auditor
Company : Torrent Research Centre of Torrent Pharmaceutical Ltd
(India's First GLP Certified Pharmaceutical Company)
Job Profile : Functional responsibility as Quality Assurance and Regulatory Affa
irs Executive
Some major responsibilities include:
Participated in 4 Discovery Projects as an GLP Auditor for various pre-clinica
l studies that includes In-Vitro Mutagenicity (Ames test), Acute, Sub Acute Toxi
city, Local Tolerance (Dermal, Mucus, and Skin sensitization), Micronucleus, Tox
icokinetic, Safety Pharmacology and to the supporting activities like Analytical
, Bioanalytical Method Validation and Formulation Studies of the Lead molecules
As Clinical and Bioanalytical Auditor, audited more than 30 BA/BE studies
Involved in reviewing qualitatively more than 500 SOPs related to preclinical
(Toxicological studies, Animal House and BSL unit), clinical, bioanalytical, sta
tistical and QA process.
Concerned with identifying, documenting and investigating deviations and provi
ding recommendation for corrective and preventive action (CAPA)
Was involved in conducting a failure investigation for a regulatory preclinica
l study (Toxicokinetic)
Performed Gap Analysis and recommendation towards Computerized System qualific
ation (Scientific Data Management System)
Developed the Change Control and Deviation Reporting concept, In-House Trainin
g program and workshops, archiving.
Handled OECD's Good Laboratory Practice inspection conducted by GLP Monitoring
Authority, Netherlands twice, assisting the organization to pass the inspection
successfully
Handled Brazilian GCP Inspection Program twice conducted by ANVISA towards Bio
equivalence studies

ACHIEVEMENTS

Presented a poster presentation titled "Team Excellence: An Important Factor T


hat Contributes To Quality Culture"- at BARQA (British Association of Research Q
uality Assurance) 2010 Annual Conference - Leeds on 2nd -5th November 2010.

Presented a poster presentation titled "Performance Measurement of the Documen


tation Practice in a Non-Regulated Research Area" at BARQA (British Association
of Research Quality Assurance) 2009 Annual Conference - Brighton on 28th October
2009.

Awarded with Third Prize by BARQA's Publication Committee (British Association


of Research Quality Assurance), United Kingdom for the article titled "QA Profe
ssional: Attributes and Roles".

PROFESSIONAL QUALIFICATIONS

M. Pharm specialization in Quality Assurance; Rajiv Gandhi University Of Health


Sciences, Bangalore, 2001 securing 1st Class
B. Pharm; Bangalore University, Bangalore, 1998, securing 1st Class

ADDITIONAL PROFESSIONAL COURSES

Diploma in Pharmaceutical Marketing Management; Institute Of Pharmaceutical Ed


ucation and Research, India on August'1996
The Principles of Good Laboratory Practice for the Professional Auditor conduc
ted by British Association of Research Quality Assurance (BARQA)-United Kingdom
on August 19th, 2005
Decision Points in Drug Development (Distance Learning) from Pharmaceutical Ed
ucation and Research Institute, Inc (PERI)-USA on October 28th, 2005
ISO 19011:2002 (Quality and/or Environmental Management Systems Auditing) cond
ucted by British Association of Research Quality Assurance (BARQA)-United Kingdo
m on November 4th, 2005

USFDA's course "Drug Review and Related Activities in the United States" scori
ng 89.47 %

Inspector Self-Study: eLearning, from The College of American Pathologists on


March 12th, 2006

ICH*Good Clinical Practice Guideline Course from Infonetica Ltd endorsed by Ro


yal Holloway, University of London on August 7th, 2010
Open Access GCP Test from Pharmaschool UK on August 10th, 2010

Earned the Registered Quality Assurance Professional Position in Good Laborato


ry Practice from Society of Quality Assurance (SQA)-USA on 29th October, 2010

ICH-GCP; British Association of Research Quality Assurance (BARQA)-United King


dom on November'2010

UK Clinical Trial Regulation; British Association of Research Quality Assuranc


e (BARQA)-United Kingdom on November'2010.

PROFESSIONAL TRAINING

GMP Training:2002
i. GMP-The ICH Guide for API Manufacturers
ii. GMP during the Development of New Drug Product
ISO 17025 Training: 2003
i. Inter-Laboratory Proficiency Testing For Calibration and Testing Laboratories
ii. Statistical Method In Proficiency Testing

GLP Training-WHO (World Health Organization-TDR):2003

Information Management Training: Agilent Technologies,2004


Information Management Solutions for the Pharmaceutical QA/QC And Development La
boratory

Specialized Training: 2004-2005


i. Quality Systems in Analytical Laboratories-2004
ii. Laboratory Quality System Management & Internal Audit Based On ISO/IEC/17025
-2005

GCP Training: 2005


Advanced Good Clinical Practice

Professional Training: 2010


i. Building and Leading High Performance Team
ii. Emotional Intelligence

PROFESSIONAL TRAINING CONDUCTED

"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"

PROFESSIONAL ASSOCIATION

Member of British Association of Research Quality Assurance (BARQA)-United Kin


gdom.

Active member of Society of Quality Assurance (SQA)-USA.


Member of SQA GLP Specialty section;2010
Professional Member of Institute of Clinical Research (ICR) - United Kingdom.
Life Member of Indian Pharmaceutical Association.

PERSONAL INFORMATION

Experienced and possess the knowledge of Drug Development Activities (From pre
clinical to clinical phase-1)

Maintain an up to date knowledge of appropriate national and international GCP


and GLP legislation and guidelines

Creativity, flexible and sincere

Ability to prioritize and work in a dynamically changing environment

Capable of analyzing and debating more complex issues with customer

GCP and GLP consultancy to project team

Ability to travel up to 30% of the time on average


Linkedin Profile to view recommendation : http://in.linkedin.com/pub/sunando-bas
u/13/526/846

Potrebbero piacerti anche