Quality Assurance Manager

Curriculum vitae

PRASHANT SOMWANSHI

Quality Assurance Manager (GLP)

(M Pharm. QUALITY ASSURANCE)

Member of the Society of Quality Assurance

Email: **.*********@*****.***

Quality Assurance Unit/GLP Section

More than 5 years of expertise in:

Documentation Quality Assurance System GLP Environment

ACHIEVEMENT

Establishment of a GLP Lab

EMPLOYMENT SKETCH

Current Organization : Meghmani Organics Limited

Position : Head of Quality Assurance Unit

Designation : Quality Assurance Manager

Department : Quality Assurance Unit (QAU GLP)

Duration : From December 2016 onwards

Previous Organization : Jai Research Foundation

Designation : Quality Assurance Officer

Department : Quality Assurance Unit (QAU GLP)

Duration : From October 2014 to October 2016

Previous Organization : Advinus Therapeutics Ltd.

Designation : Quality Assurance Research Scientist-I

Department : Quality Assurance Unit (QAU GLP)

Duration : From July 2012 to October 2014

JOB RESPONSIBILITIES

Primarily responsible for the QA functions in the studies conducts in the Bio-analytical, Residue/Analytical, Formulation & Phys-Chem, Eco-toxicology, Environmental Fate and Metabolism(EFM), Mutagenicity(AIMS&MNT) and Toxicology(Acute) department and generate inspection reports.

Review of SOPs and verification of the Study Plans/Protocols with respect to the information required for compliance with Principles of GLP and to document the verification.

To maintain copies of all approved Study Plans/Protocols and SOPs in use in the test facility (as common documents for use at QAU).

Updating of master schedule for QA inspection information.

Plan, Schedule and Conduct the inspections to determine all studies are conducted in accordance with Principles of Good Laboratory Practice. By performing all three types of inspections as Study-based inspections, Facility-based inspections, Process-based inspections and maintain the records of such inspections should be retained

Promptly report the QA inspection findings to SD, Author, Section Head, Principal Investigator (whichever applicable) and TFM.

To sign raw data sheets/recording formats (during inspection) as a proof of inspections.

Assuring the Study Plans/Protocols and SOPs have been made available to study personnel, by inspection of experimental phase.

Ensuring the Study Plans/Protocols and SOPs are followed, by inspection of data and reports.

To inspect Final Reports to confirm that the methods, procedure and observations are accurately and completely described and that the reported results accurately and completely reflect the raw data.

To prepare the QA statement to be included in Final Report which specifies types of inspection and their dates, including the phase(s) of the study inspected, and the dates on which the inspection results were reported to management and the Study Director/Principal Investigator(s), if applicable. This statement would also serve to confirm that the Final Report reflects the Raw Data.

Other Responsibilities

Participation in periodic discussions with Project Management, Business Development Departments, Test Facility Management, Study Director/Principal Investigator and other staff of test facility.

Participation during facility visits by Sponsors and Inspectors.

Helping in maintenance of QA records

Review of SOPs, preparation and updating of SOPs of QAU.

Inspection of Test Items for Archiving and Disposal of Test Items.

Ensure review of documents (SOPs, Study Plans, Reports or others) relating to application of GLP principles in multi-site studies, inspection/auditing of such studies (including field studies) and providing QA statement, as applicable. Also, to function as Lead QA and/or test site QA, as applicable, to multi-site studies.

To train new recruits to the QAU.

Document and report quality and compliance issues to Test Facility Management according to required timelines and assist in preparation and review of corrective and preventive action (CAPA) plans.

AUDIT EXPOSURE

NGCMA, USFDA, Netherlands GLP and Sponsor Audits

CORE COMPETENCIES

-Sound knowledge of FDA/EPA/OECD/CIB Guidelines & Regulations

-GLP Principles Adoption, Monitoring, Auditing, Reporting

-Audits for Compliance with Regulations, Protocols, and SOPs & Reports

-GLP Training (with the monthly and yearly effective training module)

-Documentation - Team Management - Monitoring Studies

-Analytical Skills - Problem Solving Skills - SOP Management

-Equipment Validation - Effective Communication - Audits/ Inspection

-Time management - Vender Audits - Ability to manage multiple Projects

EDUCATIONAL QUALIFICATION

Examination Passed

Examining Board/ University

Year of Passing

Marks Secured as Percentage

M Pharm

(Quality Assurance)

JSS University

2012

85 (Gold Medalist)

B Pharm

Rajasthan University of Health Science

2009

76

GPAT Qualified in year 2010

M Pharm Project Title: New method development and validation of Temozolamide Nano particles and Bio-Distribution in rats.

Professional Membership:

Life member of “Indian Pharmaceutical Association”

Outreach member of the “Society of Quality Assurance”

Registered member of “Rajasthan Pharmaceutical Council”

PROCEEDINGS IN CONFERENCES/ SYMPOSIA

Attended Indoamerican pharmaceutical regulatory symposium at Sri Ramachandra University, Chennai, Nov 20-21, 2010

Attended Indo-European symposium on Alternative approaches to animal testing in the year, Dec 8, 2010 held at Ooty

Participated as a delegate and attended Indo-US symposium on Frontiers in Medicinal Chemistry & Drug Discovery, Molecule to Medicine, held at Mysore, 21-23 April, 2011

TRAININGS/ WORKSHOP ATTENDED

Attended Training course for QA Personnel of GLP Test Facilities on 15-17th Nov.2016 by NGCMA

Workshop on Computer System Validation and Data Integrity by UBM India on 5-6th Aug 2016

Successfully undergone Training of Emergency Response Training Programme on May2016, June 2016 & July 2016 respectively conducted by LCS India

Data Integrity and Computerised Software Validation, held at Daman, Feb 24th, 2015

Completion of training and awareness programme on TATA Code of Conduct, held at Bangalore, Dec, 2012

Attended GLP Training Programme at Advinus, Bangalore, 2012 and Jai Research Foundation, Vapi, Gujarat, 2014

Advinus Finishing School, held at Bangalore, 31st Dec, 2012

Visited Pharmaceutical Manufacturing plant, Boro Cap Pharmaceuticals, Jaipur, 20th October, 2009

IPA students forum industrial visit-attended training at Cipla, Alkem, Glenmark Pharmaceuticals at Mumbai

COMPUTER PROFICIENCY

Working Knowledge of MS-Office, Windows and well versed with Internet.

PERSONAL DOSSIER

Name : Prashant Somwanshi

Date of birth : 08 August 1988

Language known : English and Hindi

Marital Status : Married

Permanent Address : Plot No. 51 Moti Nagar Jaipur Rajasthan

REFERENCES

Muktha Bhagwan • Dr. Rajendra N. Nagane

Deputy Section Head QAU (GLP Auditor) Assistant Director

Advinus Therapeutics Limited Jai Research Foundation

Bangalore 560058 Valvada 396105

Contact No.: +919********* Contact No.: +919*********

Email: ******.*******@*******.*** Email: ********.******@*********.***

Ram Prakash • Dr. J.S.K. Nagarajan Ph.D.

Quality Assurance Unit (GLP Auditor) Professor and Director of PADRAD,

Senior Research Scientist Two Dept. of Pharmaceutical Analysis,

Advinus Therapeutics Limited JSS College of Pharmacy, Ooty,

Bangalore 560058 Contact No: +91-944*******, 944-***-****

Contact No.: +919********* Email: ************@**********.***

Email: ***.*******@*******.***

DECLARATION

All the information furnished above is true and correct to the best of my knowledge and belief.

Date:

Place: Ahmedabaad Prashant Somwanshi

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