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Quality Assurance Development

Location:
Hyderabad, AP, India
Salary:
3.0 to 4.0 lac per anum
Posted:
July 06, 2013

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Resume:

OBJECTIVE:

Mr. Gabani Bhavesh B To pursue a challenging career in your esteemed

Officer,

organization and utilize my professional knowledge

Clinical Research Center,

of the subject and practical skills for the growth of

Mylan Laboratories. Ltd.,

the organization.

Hyderabad, India.

AREAS OF INTEREST:

• Analytical Research and Development.

Contact Details:

• Bio analytical and Bio analytical Quality Assurance

Contact No. : +91-814*******

• Quality Assurance

Email: ab0ke9@r.postjobfree.com

PROFESSIONAL WORK EXPERIENCE:

Working as an officer in Clinical Research Center at Mylan Laboratories Ltd. (A

subsidiary of Mylan Inc., USA) since November 2011 till date.

PROFESSIONAL WORK PROFILE:

MYLAN LAB. LTD:

Method Development and validation of Analytical, Bioanalytical and In-vitro

bioanalytical method by LC-MS-MS, HPLC and Ion Chromatography as per US-

FDA, WHO, EMEA, TGA and ANVISA guidelines.

Sample preparation and analysis through SPE, LLE, and protein precipitation.

Responsible for calibration and maintenances of sophisticated instruments like HPLC,

Ion chromatography, Analytical balance, pipette and pH meter etc.

Responsible for Preparation and Review of SOPs, AMP, Study and Validation Protocol,

Calibration and Validation Documents.

Ensuring error free documentation by adhering to GLP/GDP principles.

Actively involved in making site ready for regulatory inspection like USFDA, WHO and

Thailand FDA.

Responsible for review of validation Protocol and Report.

WORK DURING M.PHARMA:

Development and validation of stability indicating assay method for estimation of drug

substances using HPLC and HPTLC technique as per ICH guideline.

Analytical method development and validation as per ICH guidelines.

Dissolution studies as per IP and USP.

Solubility studies to increase the poorly soluble drugs by using shake flask method.

In situ intestinal perfusion studies in rats.

TECHNICAL PROFICIENCY

Handling Proficiency of Equipment:

LC-MS/MS API-4000 & 5500, Waters XevoTQMS and Xevo TQ-S

Ion chromatography ( Dionex, model; ICS3000, ICS5000 with electro chemical

detector, conductivity detector, VW detector)

HPLC with UV, PDA and Fluorescence detector (Waters and Shimadzu Prominence

systems having software like Millenium, LC Solution, Classvp)

HPTLC, Spectrophotometer and Spectrofluorometer

DISSERTATION PROJECT TITLE: “High Performance Liquid Chromatographic Method

for Quantitative Determination of Atorvastatin and its Major Metabolite in Rat Plasma and

Application to a Preclinical Pharmacokinetic Study”

SEMINARS DELIVERED:

Analytical method validation-similarities and differences according to different

regulatory guidelines.

Stability testing of Phytopharmaeuticals.

STRENGTHS

Can quickly adapt to situations and keen and quick learner.

Self- confident and hardworking

Analytical bent of mind and a positive attitude.

Team player with strong interpersonal and organizational skill

EDUCATIONAL QUALIFICATION:

Qualification Institution University / Board Year %

M. Pharm

Manipal College of Aug-

Pharmaceutical

Manipal University 69.08

Pharmaceutical Sciences 2011

Quality

Assurance

B. Pharm Manipal College of June- 8.45

Manipal University

CGPA

Pharmaceutical Sciences 2009

S.E.T’S College of

Jan-

Karnataka drug

D. Pharm 66.30

P harmacy, Dharwad,

control board 2006

K arnataka.

Shree Swaminarayan

Mar-

Gujarat HSC Board,

H igh School,

12th 66.15

Apr

Gandhinagar

Sardarnagar,

2002

B havnagar, Gujarat

Shree Sahjanand

Gujarat Secondary May-

10th 67.00

H igh School, Botad,

Education Board 2000

Gujarat

PERSONAL DETAILS

: 1th October 1984

Date of Birth

Marital status : Married

Father’s name : Gabani Babubhai N

Languages Known : English, Gujarati and Hindi

Permanent Address : Stree No. 4, Hifli, Patel soc., Bairajba wadi, Botad-36471

Dis.: Bhavnagar, State: Gujarat.

Present Address : 307- Shreegiri Apartment, near GHMC Park, Sainik Enclave,

Sainikpuri, Hyderabad- 500094. State: Andhra Pradesh.

P ROFESSIONAL REFERENCES:

Dr. Krishnamurthy Bhat

Professor and head,

Dept. of Pharmaceutica Quality Assurance,

MCOPs, Manipal-576 104

E-mail: k ab0ke9@r.postjobfree.com

Mobile No: +919*********



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