Training Clinical Research

CURRICULUM VITAE

PERSONAL DETAILS:

Name : Ashok Ghoghari

Qualification : M. Pharm

Date of Birth : 07 Aug 1977

Core Area : Bioanalytical

Marital Status : Married

Nationality : Indian

Mobile : +91-987*******

E-mail : **************@******.***

EDUCATIONAL QUALIFICATIONS:

Sr. no. Degree Specialization Year of Passing University/ Institute

01 Master of Pharmacy Phrmacognosy & Phytochemistry 2004 Gujarat Ayurved University, Jamnagar

02 Bachelor of Pharmacy Pharmacy 2000 Rajiv Gandhi University, Bangalore

03 H.S.C Science stream 1995 Maharashtra Board, Mumbai

04 S.S.C General 1993 Gujarat Board.

CURRENT EMPLOYMENT:

Organization : Zydus Research Centre, Cadila Healthcare, Ahmedabad, India.

Department : Bioanalytical Research

Designation : Project In-charge/ Sr. Research Associate

Duration : 30 Sep 2010 to till date.

Reporting to : Head of the Department.

Responsibilities:

• Working as a Group Leader.

• Ensure appropriate & technically valid Standard Operating Procedures & formats to be established for test method & related to functional area.

• Ensure the complete training on Regulatory Guideline, Standard Operating Procedures related to functional area, management and on job training on instruments & test procedures to produce high quality study results.

• Literature search, define & design method development strategy for new Bioanalytical method development.

• Preparation of test method, method validation protocol & review of validation & analytical report.

• Bioanalytical method finalization, pre-method validation and method validation for assigned projects, raw data hard copy & soft copy archiving, recording, verification and review.

• Carry out clinical sample preparation and analysis, acceptance of analytical runs as per sops, compilation of raw data, monitoring of sample preparation process by study analyst.

• Carry out or monitor or coordinate routine, preventive maintenance, validation and calibration of equipments and verification of records for its compliance to SOP.

• Daily monitoring of all facility area for compliance of GLP & Quality norms.

• Carry out SOP training, technical assessment, on job training and analyst validation for junior study analyst.

• Reply to relevant QA queries in co-ordination with team members.

• Guide and supervise Group members for assigned activities.

• Developed and validated 10 methods and performed 12 projects of BA/BE studies from Oct 2010 to till date at Zydus Research Centre.

PREVIOUS EMPLOYMENTS:

Organization : Veeda Clinical Research, India.

Department : Bioanalytical Research

Designation : Group Leader

Duration : 03 Oct 2006 to 28 Sep 2010.

Reporting to : Head, Lab Operations.

Responsibilities:

• Working as a Group Leader and handling group of 4 peoples.

• Method Development and Method Validation of generic and NCE molecules from plasma, blood and urine using different extraction procedures like Solid-Phase Extraction (SPE), Liquid-Liquid Extraction (LLE) & Plasma Protein Precipitation (PPT).

• Project Handling: Individually handled projects related to Bioequivalence and Bioavailability of pharmaceutical drug and worked in team in many projects using FDA Guidelines under complete GLP Set up.

1. Assigning resources for project

2. Tracking the progress and completion of project(s)

3. Data review

4. Managing inventory

• Calibration and maintenance of HPLC, MSMS.

• Preparation and review of SOPs, Protocols, plans and reports.

• Execution and maintenance of GLP, GCP, Safety and Quality Systems.

• Reply to relevant QA queries in co-ordination with team members.

• Responsible for training and upgradation of group members and updating their training needs.

• Responsible to archive the relevant data.

• Responsible to appraise group members.

• Guide and supervise Group members for assigned activities.

• Developed and validated about 10 methods and performed about 60 projects of BA/BE studies from Oct 2006 to Sep 2010 at Veeda Clinical Research Pvt Ltd.

Organization : B. V Patel Pharmaceutical Education and Research Development (PERD) Centre, Ahmedabad.

Department : Pharmacognosy and Phytochemistry

Designation : Research Associate

Duration : July 2004 to Sep 2006.

Responsibilities:

• Method Development and Method Validation of phytochemicals by HPTLC, HPLC and spectrophotometrically as per ICH Guidelines.

• Isolation of phytochemicals using Column Chromatography

• Fingerprinting profile and antioxidant activity of medicinal plant extracts and herbal formulations

• Microscopy of medicinal plants and herbal formulations.

Organization : Institute of Medicinal Plant Sciences, Gujarat Ayurved University, Jamnagar.

Department : Pharmacognosy and Phytochemistry

Designation : Technical Assistant

Duration : May 2004 to Jun 2004.

Responsibilities:

• Microscopy of medicinal plants.

Organization : Oboi Laboratories, Mumbai.

Department : Registration and Document Department

Designation : Officer

Duration : May 2004 to Jun 2004.

Responsibilities:

• Preparations of Dossiers

• Assisting production of injectables.

EQUIPMENTS HANDLED:

• HPLC, Shimadzu LC-VP Series

• UPLC, Waters

• MS/MS-MDS SCIEX API 2000

• MS/MS-MDS SCIEX API 3000

• MS/MS-MDS SCIEX API 3200

• MS/MS-MDS SCIEX API 3200 Q-TRAP

• MS/MS-MDS SCIEX API 4000

• Millipore Water Purification System Elix & Milli-Q

• HPTLC, CAMAG.

AUDIT FACED:

• US FDA, USA

• ANVISA, Brazil

• WHO

• MHRA

• Audits of Pharmaceutical Company’s like Pfizer, Novartis, Teva etc for Bioanalytical work.

TRAINIG/CONFERENCES:

• Basic Operator Training on LC/MS/MS (API 4000) including calibration conducted at, Lab India Research and Development Laboratory, Gurgaon; 28-30 October, 2009.

• Basic Operator Training Course on MDS SCIEX API 4000 LCMS/MS Systems conducted by Lab India Instruments Pvt. Ltd at Veeda Clinical Research Pvt. Ltd, Ahmedabad; 27-29 May 2009

• Workshop on troubleshooting & maintenance of Shimadzu High Performance Liquid Chromatography (HPLC) conducted by Spinco Biotech Pvt. Ltd., Ahmedabad, Date: 10 Jan 2008.

• Basic Trainig on the Principles and Implementation of Good Laboratory Practices (GLP) Organized by Veeda Clinical Research Pvt. Ltd, held at Ahmedabad Management Association, Ahmedabad, Duration: 23 Apr – 25 Apr 2007.

• Basic Training on Good Clinical Practices (GCP) Organized by Veeda Clinical Research Pvt. Ltd, held at Ahmedabad Management Association, Ahmedabad.

Date: 22 Jan 2007.

• Indian Phrmaceutical Congress (IPC), Hyderabad, Dec. 2005

• Indian Phrmaceutical Congress (IPC), Kolkata, Dec. 2004

• 4th International Seminar on Ayurveda for Better Health, Gujarat Ayurved University, Jamnagar, January 2004.

PUBLICATIONS:

• Ashok M Ghoghari., M. Rajani. Densitometris determination of hecogenin from Agave Americana leaf using HPTLC. Chromatographia, Vol. 64, No. , 2006.

• Ashok M Ghoghari., M. S. Bagul, S. S. Anandjiwala, M. G. Chauhan, M. Rajani. Free radical scavenging activity of Aspidium cicutarium rhizome. Journal of Natural Remedies, Vol. 06, No. 2, Jan 2006.

• Ashok M Ghoghari, M. G. Chauhan. Phrmacognostical and phytochemical evaluation of Aspidium cicutarium rhizome. Indian Journal of Natural Products, Vol. 22, No. 1, March 2006.

• Technical Assistant of book entitled “Microscopical profile of powdered Drugs used in Indian System of Medicine: Vol. 1-Bark Drugs” published by Institute of Medicinal Plant Sciences, Gujarat Ayurved University, Jamnagar.

REFERENCE:

Dr. Malti G. Chauhan, Ph.d.

Dean, Institute of Medicinal Plant Sciences.

Gujarat Ayurved University.

Jamnagar, Gujarat, India.

Mob: +91-989*******.

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