www.bharatserums.com Bharat Serums And Vaccines Ltd Thane : Regulatory Executive

[muthukalee]

bharatserums.com
Regulatory Executive

Job Description

Job Code : REGEX

Position : Regulatory Executive

Description : B.Pharm/B.Tech (Biotech), 1-3 yrs in Regulatory Affairs preferably with exposure in handling Biotech/Biological products Type of Work to be done: Dossier preparation ,Co-ordination with Support functions such as R&D,QA/QC, Procurement, Co-ordination with Country Regulatory in order to file registration dossiers & respond queries,

Location : Thane

Skill Set : Well versed with Computers, Good in communication skill,should be able to work independently,

Experience : 1-3 years

Qualification : B.Pharm or B.Tech in Biotech

Salary Range : 2,00,000-3,00,000 p.a

Department : Quality Operations

About us :
Since inception in 1971, BSV has worked ceaselessly to research, develop, manufacture and market specialized biological, pharmaceutical and biotechnology products. Today, BSV is one of the fast growing Indian bio-pharmaceutical companies. The product portfolio comprises of a wide range of products such as plasma derivatives, monoclonals, hormones, equine antitoxins and serums, antifungals, anaesthetics, cardiovascular and diagnostic products.

Contact us:
Bharat Serums And Vaccines Ltd
Plot No. A-371-372, Road 27,
Wagle Industrial Estate,
Thane – 400604.
Maharashtra, India.

http://bharatserums.com/job.jsp
http://bharatserums.com

[Guest]

respected sir,
i am Milind Patil a student of M Pharmacy in P'ceutical Chemistry
i m also doing MBA.
i am looking for job in R & D
for that please contact me on mobile no. or you can mail at m.a.patil1987@gmail.com
thank you!

[Guest-IJT]

RESUME

JYOTI NUNSE

Objective:

To pursue a challenging carrier in a progressive organization that gives me scope & zeal to enhance my knowledge and skills and be a part of the team excel in work towards the growth of the organization.

Current Position:

PRODUCT EXECUTIVE at GEO PHARMA PVT LTD, Mumbai, India, (Aug 09 till date)

Job Experience:

- Worked as Medical trainee for Shrikant Druggist and Chemist Medical Store for 8
months.
- 4yrs as taking tuitions (11th-12th Science students & Pharmacology subject to MBBS
Students)
Industrial Training

1. BLUE CROSS LABORATORIES LIMITED, A-12 AMBAD INDUSTRIAL AREA, NASHIK.

2. GLAXOSMITHKLINE, PHARMACEUTICALS LIMITED, A-10, M.I.D.C.,
AMBAD, NASHIK.24TH JUNE 2008.

Professional Qualification


- Passed Degree in Pharmacy from Pune University in April -2009 with distinction
- in Pharmacology & Pharmaceutical Analysis.
- T.Y. Bachelor in Pharmacy, from Pune University,
- Percentage :63, Marks :756/1250
Distinction: Pharamacology- 143

Educational Qualification
- MAH-PH-CET – Qualified ( CAP SELECTION )
- MH-CET – Qualified
- H.S.C in Science from MAH-BOARD, S.V.K.T. College of science, Devlali Camp, Nashik and secured second class in the year 2004
- S.S.C. from MAH-BOARD, Devlali Camp, Nashik and secured second class in the year 2002.

Computer Literacy:
Proficient with MS- Word, Excel & usage of the Internet.


Special Awards and Recognition

- “INDIAN ASSOCIAITON OF PHYSICS TEACHERS NATIONAL STANDARD EXAMINAITON IN PHYSIC 2003-2004 (At class XII). BARC (Babha Atomic Research Centre) awarded among top 10 in examination.

Seminars

1. TWO-DAY NATIONAL SEMINAR ON RECENT ADVANCES IN NANO
SCIENCE FEBRUARY 23RD & 24TH 2008.(PHARMACOGENOMICS)
POSTER PRESENTATION IN SUB CENTER OSMANABAD.
2. “Quality Control” and “Quality Assurance” in S.N.D College of Pharmacy


Project
- “Isolation of DNA of E.coli” in 3rd year.


Hobbies and Interests
Working for Industrial Project, Traveling, making friends and listening to music.

Additional Responsibilities
1. Providing guidance to my juniors.
2. Preparing for GATE Exam.

Personal Details

Full Name : Nunse Jyoti Mangal
Date of Birth : 24th September 1985
Gender :
Marital Status: Single
Nationality : Indian
Religion : Hindu

Languages Known : English, Hindi & Marathi (read,

[Guest]

SUNITA PAVANKUMAR PATIL
Email : sunitapv_patil AT rediffmail.com
OBJECTIVE
I aspire to use my skills and knowledge to achieve and attain aluminous position in the pharmaceutical industry, by working my level best towards the betterment of the organization and self development
CAREER HIGHLIGHTS AND SKILLS
Regulatory Affairs :
* Compiling & documentation of wide range of datas and information of Regulatory affairs.
* Knowledge of regulatory guidelines of various semi regulatory countries.
* Information of regulatory strategy, regulatory intelligence and regulatory compliance .Knowledge of various ICH guidelines and cGMP guidelines.
* Preparation of registration dossiers for semi regulatory countries according to their official guidelines like Ukraine, Kazakistan , Philippines , Thailand , Shrilanka , Bhutan , Ethiopia, Ghana and Uganda. Latin American countries : Bolivia, Columbia, Peru, Mexico, Guyana and Honduras
* Furnishing the scientific responses to deficiency queries received from various regulatory bodies.
* Application of Manufacturing Licenses for new products and COPP.
* Carrying out the review of BPRs, Deficiency Queries & Response, BPR, PDR, Process Evaluation Data, etc.
* Carrying out the review of validation & exhibit reports, stability data, dissolution data, specifications, incidents, patents, etc.
* Have acquaintance with CTD filling to various regulatory bodies.
* Co – ordination with QA, QC and Production departments for getting samples and documents.
* Co – ordination with QA, procurement department and vendors to get approved artwork and printed packaging material for registration.
Analytical Chemistry :
* Acquainted with various spectral techniques such as IR, UV-VISIBLE, and HPLC.
* Reviewing of analytical data received from QC department.
Computer Skills
* Windows, Microsoft Office, Acrobat, Internet etc.
WORK EXPERIENCE
- Nov 2009 – June 2010,Cipla Ltd, Vikhroli as Officer in Pharma Regulatory Affairs department.
- Mar 2009 – Nov 2009, M/S Kilitch Drug India Pvt. Ltd. Navi Mumbai as Officer in Pharma Regulatory Affairs department.
- June 2007, Industrial trainee, ratiopharm India Private Limited Verna, Goa -403722. One month industrial training taken in following dept : Quality Assurance, Analytical Development, Formulation Development and Scale Up and Quality & stability Control.
EDUCATIONAL QUALIFICATION
EXAMINATION BOARD / UNIVERSITY CLASS YEAR
10th Kolhapur Board 1st class (73.86%) March 2002
12th Kolhapur Board 1st class (66.50%) Feb 2004
B.Pharmacy Shivaji University (MH) 1st class (61.00%) May 2008
PG Diploma in Industrial Analytical Chemistry Ramnarain Ruia College, Mumbai Appeared July 2009
SEMINARS AND PROJECTS
- Seminar presentation on Mass Spectrometry during I st semester as part of curriculum of
PG-DIAC.
- Project on Green Chemistry submitted to Ramnarain Ruia College, Mumbai as part of curriculum of PG-DIAC.

[Guest]

CURRICULUM VITAE

Name : Miss Sulakshana H Chavan,
Email :- 1)sulakshana_bhilare AT rediffmail.com
Objective :
To work at responsible position in an organization where I can utilize my technical skills to contribute towards the excellence and growth both as professionally & as an individual and pursue a challenging roles in dynamic concern and achieve perfection through performance in the pharmaceutical field.
WORK EXPERIENCE
Worked with Gharda Chemicals Ltd as an assistant officer in Quality Assurance Department(Training -6 months)
Instruments Handled :
1) Ultraviolet Spectroscopy
2) Atomic Absorption Spectroscopy
3) pH meter.
4) Conductivity meter.
5) IR Spectroscopy

Educational Qualifications :
Academic Qualification : M.Sc.
Specialization : Biochemistry From: Dr.John Barnabas P. G. School for Biological Studies, Ahmednagar College, Ahmednagar.
Degree University/Board Year Percentage Class Obtained
M.Sc. (Biochemistry) Pune University June
2008 56.15% IInd Class
B.Sc. (Microbiology) Pune University July
2005 62.83% 1st Class
H.S.C. H.S.C.Board Pune May
2002 60.61% 1st Class
S.S.C. S.S.C.Board Pune June
2000 72.92% 1st Class
Technical skills :
- MS-office ,Basics, Internet
Review : Artificial Ribozymes
Project :

“INDENTIFICATION OF INHIBITORS FROM TRIDAXS PROCUMBENS .”
During my M.Sc.course I have completed project on Identification of inhibitors from Tridax procumbens and their interaction with proteases carried out under the guidance of Dr.R.D.TAK,Lecturer, John Barnabas post graduate School of Biological sciences, Ahmednagar college,Ahmednagar
Coursework during M.Sc.
Endocrinology, Molecular Biochemistry, Genetic Engineering (RDT), Enzymology, Toxicology, Biophysical Techniques, Plant Biochemistry, Metabolism, Physiology, Medical Biochemistry, Membrane Biochemistry, Microbiology, Cell Biology, Biomolecules
Exposure to :
During my academic pursuit I havebeen exposed to various scientific technique
Separation Techniques
- PAGE
- Column Chromatography.
- Protein Isolation
- Serum Protein etc.
- Isolation and estimation of DNA (E. coli,Liver) and
RNA (Yeast).
- Carbohydrate – protein : detection and estimation
- Enzyme Kinetic Studies.
Desired Location : Mumbai and Mumbai sub urbans

[Guest]

CURRICULUM VITAE

RUPALI N. NARKHEDE
Email - rnrupnar23 AT gmail.com

Educational Background :
Diploma in Pharmaceutical Q.A. & Q.C. Management August 2008
I.P.E.R. Pune
Scored 58.00 %
Bachelor of Pharmacy May 1999
North Maharashtra University
Scored 59.09 %

Diploma in Pharmacy May 1994
Maharashtra State Board
Scored 70.41 %

Work Experience :
- At present working with SANDU Brothers Pvt. Ltd, Nerul, Navi Mumbai as ‘Quality Control & AMD - Incharge’ since 3rd Jan 2011.

Job includes :
- Supervision on Analysis of Raw Materials,Finished product as per
A.P., I.P. , B.P. & U.S.P. & packing materials.
- Supervision on Analysis of Stability samples in scheduled time.
- Correlate with production,Store & Purchase department.
- Responsible for all QC activities in accordance with prevailing GLP.
- To motivate & train to all laboratory analysts.
- Investigate customer complaints & implement corrective actions.
- Preparation of SOP’s , STP’s, Stability protocols & Standard
Specifications.
- Responsible for the Calibration of instruments such as
Spectrophotometer, Polarimeter, Refractometer, Viscometer, Karl
fiesher , IR moisture balance etc.
- Takes an active part for the preparation of audits such as WHO GMP,
FDA, ISO & NABL.
- Responsible for the Standardisation of Herbs.
- Analysis of Raw Herbs
- TLC finger- printing of Raw Herbs, Extracts & Finished products.
- Estimation of Active ingredient in Raw Herbs
- Method validation
- With Charak Pharma Pvt. Ltd, Mumbai as ‘Sr.Quality Control Officer’ in Analytical Method Development, R&D,Mahalaxmi, Mumbai from 4th April 2005 upto 31st Dec 2010.
Job includes :
- Analysis of Raw Materials as per A.P., I.P. , B.P. & U.S.P.
- Analysis of Finished products
- Standardisation of Herbs.
- Analysis of Raw Herbs
- TLC finger- printing of Raw Herbs, Extracts & Finished products.
- Estimation of Active ingredient in Raw Herbs
3 Preparation of SOP’s , STP’s, Stability protocols & Standard
Specifications.
4 Handling & Calibration of instruments such as Spectrophotometer, Polarimeter, Refractometer, Viscometer, Karl fiesher , IR moisture balance etc.
5 Takes an active part for the preparation of audits such as WHO, FDA,
ISO & NABL.
- With Abhinav Health Care Products Pvt. Ltd. Wada, Thane as ‘Quality Control Chemist’ from 02/02/2004 upto 31/03/2005.

Job includes :
- Analysis of Raw Materials as per I.P., B.P. & A.P. & Checking of the packing materials
- I.P.Q.C. checks over the production activities
- Preparation of SOP’s , STP’s & Standard Specifications.

- With Herbina Products India, Dehuroad, Pune as ‘Quality Control Chemist’ from 01/06/2002 upto 27/01/2004.
Job includes :
- Analysis of Raw Materials as per I.P. & B.P.
- Handling & Calibration of instruments such as Spectrophotometer,
Polarimeter, Refractometer, etc.
- With Health Care Pharma,Tathawade, Pune as ‘Quality Control Chemist’ from 02/05/2000 upto 15/03/2002.
6 Analysis of Raw Materials as per I.P., B.P. & Checking of the packing
materials
- I.P.Q.C. checks over the production activities
- Preparation of SOP’s , STP’s & Standard Specifications.

- With Biogenics India Ltd, Lonavla, Pune as ‘Quality Control Chemist’ for the period of 2 months.

- Analysis of Raw Materials as per I.P., B.P. & U.S.P. Checking of the packing materials
- Preparation & sterlisation of media for the microbiological testing
- Checking of the animal house
- Carried out Sterility & Pyrogen testing for Injectable formulations

1 Industrial Inplant training during the course is carried out at Haffkine
Biopharmaceuticals Corporation Ltd, Mumbai for the period of one month

Computer Literacy : Basic knowledge of Computer in MS word & Excel.

[Guest]

CURRICULUM- VITAE
Name : Varshada Krishna Gavhane.
Email : varshada1989 AT rediffmail.com
OBJECTIVE :
To pursue a challenging job and excel at it, to serve the organization with my resourceful and innovative qualities and hard work, and to reach a good position in my respective field of service.
I believe that I have to grow, excel, derive satisfaction and deliver 100% with every job I do. I believe in TEAM work because Together Everyone Achieves More.
EDUCATIONAL QUALIFICATION :
Qualification Percentage Name of the Institution University
/Board Year of Passing
B.pharm IV year 66.50% SCSSS’s SitaBai Thite College of
Pharmacy,
Shirur, Pune. Pune University April 2011
III year 67.76% April 2010
II year 69.25% April 2009
D.pharm II year 78.00% Institute of Pharmacy for Women, Ale, Alephata, Junnar, Pune. Mumbai University April 2008
I year 67.73% April 2007
HSC 47.83% Dnyanasadhana college, Thane. Maharashtra Board Feb 2006
SSC 71.86% Shri Nagar Vidhya Mandir, Thane. Maharashtra Board March 2004
Academic project :
- Project title : pharmacogenomics: the emergence and growth of personalized medicine.
Extra-curricular activities :
- Participation in One day state level seminar on STANDARDIAZATION OF HERBAL DRUG’S : NEED AND PROSPECTS .University of Pune.
- Participation in One day seminar on NANOTECHNOLOGY : ADVANCES AND INNOVATIONS. University of Pune.
- Participation in One day seminar on INTELLECTUAL PROPERTY RIGHTS : A KEY TO SUCCESSFUL RESEARCH AND DEVELOPMENT STRTERGIES. University of Pune.
Languages known :
- English, Hindi, Marathi.
Hobbies :
- Reading, Listening music, making new friends.
Computer Knowledge :
- Good working knowledge of internet application
- MS office : word, excel, powerpoint
- Operating system : windows7, XP
Personal Skills :
- Ability to work hard.
- Excellent Verbal & Writing Skills.
- Ability to coordinate with team members.
- Schedule oriented.
Area of interest :
- QA and QC
- R&D
- Formulation, Production of drugs

[sheetalkhade]

Sheetal Rajendra Khade

Email : sheetalsapkal AT gmail.com
OBJECTIVE
Achieve the best in the field of research through hard work and sincerity. Gain knowledge and use it for the productive development of organization.
CAREER SUMARRY
One and half years of experience in pharmaceutical regulatory affairs.
Experience of ANDA filings with knowledge of registration requirements of USFDA.
Experience of WHO dossiers filing with knowledge of registration requirements as per WHO guideline.
Experience in paper submissions and having knowledge of electronic submissions (E-CTD)
Experience of filing of dossier for sterile dosage form (injections)
One year of experience as lecturer in Appasaheb Birnale College of Pharmacy, Sangli.
ACADEMIC PROFILE
Course Institution Year (s) Class
M. Pharmacy (Pharmaceutical Chemistry) K.L.Es college of Pharmacy, Hubli, Rajiv Gandhi University of Health Sciences. Bangalore. 2006-08 Distinction (82%)
B. Pharmacy Appasaheb Birnale College of Pharmacy Sangli, Shivaji University 2004-2005 First Class (72%)
D.. Pharmacy Appasaheb Birnale College of Pharmacy Sangli, Shivaji University 2001-2002 First Class (73%)
PROPESSIONAL EXPERIENCE

May 2008 - Oct. 2009, experience in regulatory affairs department at Cipla Ltd, Vikhroli, Mumbai.
From Oct. 2009 to till date not in job ( Maternity Break)
Jun. 2005- May 2006, worked as lecturer in Appasaheb Birnale College of Pharmacy, Sangli.
Responsibilities :
ANDA compilation for US in CTD and old section format.
Review and comment on finalization of product specifications (API & Finished) and BMR.
Review of product development summary reports.
Filing for additional manufacturing site under variation application for WHO and PEPFAR.
Filing the additional API site for WHO and PEPFAR market.
Filing for additional API site for PEPFAR for electronic submission.
Tender requisition against orders for UNICEF, Clinton foundation.
Achievements :
Prequalification approval for two dossiers submitted to WHO.
Achieved 3 additional Mfg site (Site transfer – under variation application) approval for WHO
Achieved 2 additional API site (Site transfer – under variation application) approval for WHO
RESEARCH PROJECT
M. Pharma : Synthesis and Antibacterial Activity of the thiazolidinone Benzpyran-2-one derivatives
Guide : Mr. P.M. Road Senior Lecturer, Department of Pharmaceutical Chemistry, K.L.Es College of Pharmacy, Hubli.
ACADEMIC ACHIVEMENTS
Recipient of the Sir Ratan Tata trust scholarship for postgraduate Studies.
COMPUTER LITERACY
MSCIT-Basic Computer Course
Well trained in using computer software such as Windows, MS office, Chem Sketch, ISI Draw
Expert in Internet Search using various scientific search engines
INSTRUMENNT HANDLING
Synthesis of various compounds using Microwave synthesizer, Rota Evaporator
Experience in halding of spectroscopic (UV/Visible spectrophotometer, FTIR) and chromatographic techniques (TLC & HPLC)
RESEARCH PUBLICATION
Sheetal K, Ronad P, Noolvi N, Maddi V, Dhrabhamulla S., Sythesis and antibacterial activity of 7-(2-substituted phenylthiazolidinyl)-benzopyran-2-one derivatives. European Journal of Medicinal Chemistry, 45 (2010) : 85-89.
PAPER PRESENTATION
Role of Nano technology in New Drug Discory – Review article (International conference on Drug Discovery and Nanotechnology)
Synthesis of New Pthalazine and Pyridazine Derivatives as Vasodilator(59 IPC Varanasi)
SEMINAR ATTENDED/ PRESENTED
Recent advances in Spectroscopic techniques.
Synthesis and antibacterial activity of new series of Azetidiones benzopyran-2-one derivatives.
Recombient DNA Technology – a new tool for Epitope Mapping

[Guest]

NAME : Nivya Varghis
SEEKING POSITION OF : Clinical Research Associate
COUNTRY : India
INDUSTRY EXPECTED : Pharmaceutical/ Biopharmaceutical/ CRO
MAIL ID : nivyavarghis AT gmail.com
BEST TIME TO CALL : 9am to 8pm
BEST TIME FOR ONLINE CONTACT : 5pm to 8pm
WORK EXPERIENCE
Total no of years : 6 months
GLUMEX PHARMACEUTICALS, Vasai
Has worked as Assistant Chemist in the Quality Control Department
- Testing the quality of raw materials, finished products and packaging materials as per the drug rules
- Microbial testing of the materials, water analysis
- Documentation and maintaining the records of the materials
- Testing on UV Spectrophotometer, polarimeter, Karl fischer etc
- Coordinating with production department and assisting the Quality Head in other functions
EDUCATION QUALIFICATION
B. Sc (Microbiology) Mumbai University, India
Passed in 2009
Diploma in Basic Clinical Management & Regulatory Affairs
Haffkine Institute, Mumbai, India
Jan’ 2010
Advance Post Graduate Diploma in Clinical Research Management & Regulatory Affairs, PERRFECT CRA TRAINING CENTRE, Mumbai.
Nov’ 2010
1) Training in ICH-GCP Guidelines with respect to Tripartite Region.
2) Various Projects study with respect to undertaking clinical trials with
existing and new products.
3) Preparation of eCTD and CPMP Dossiers.
4) Assignments for Preparation of Protocols/Reports for Clinical Trial Phases
and Toxicology Studies.
5) Literature survey from Text books and Scientific Journals.
6) Research project design- Data compilation, Set Objectives, Work plan and
Experiments. Collect information about Clinical studies.
PROJECT WORK :
1) Successfully completed the project on CPMP Dossier of FOSAMAX Tablet
2) BIOEQUIVALENCE project on BACLOFEN Tablet
3) Project on INSTRUMENTATION
TECHNOLOGICAL SKILLS :
Well versed with Windows XP & Applications like MS Word, Excel, Power point with basic Internet knowledge.

[Guest]

RESUME
Ms.Kadam Smita Bapurao
E-mail : smitakadam33 AT gmail.com

Professional Objective :
I would like to be a part of the scientific research world especially in the field of Life science where my technical, communicational, experimental skills along with the academic achievements can be effectively utilized for its boost and to give my best with full capability and determination.
Academic Educational Details :
CLASS BOARD/UNIVERSITY YEAR PERCENTAGE GRADE
M.Sc Biotechnology F.Y. S.R.T.M.U,nanded 2011-12 63.16% First class.
B.Sc Biotechnology T.Y. S.R.T.M.U. Nanded 2010-11 65% First class.
B.Sc Biotechnology S.Y. S.R.T.M.U. Nanded 2009-10 63% First class.
B.Sc Biotechnology F.Y. S.R.T.M.U. Nanded 2008-09 50% IInd class.
H.S.C. Latur Board 2005-06 68.17% First class.
S.S.C. Latur Board 2003-04 64.26 % First class.
Hands of skills :
- Instrumentation : -Double beam UV Spectrophotometer, centrifuge, autoclave, pH meter, laminar cabinet, Microscopy.
- Paper and Gel Electrophoresis, Paper, TLC and Column Chromatography.
- Microbiology : -Different microbial basic techniques.
- Fermentations Techniques : -Media preparation, optimization, and Recovery.
Co curricular Activities :
- Participated in National conference on “Recent Trends in Plant Sciences For Rural Development” organized by Department of Botany, Nagnath Arts, Commerce & Science College, Aundha Nagnath.
- Participated in National conference on “Emerging Trends in Biotechnology For Modern Era” organized by Department of Biotechnoloy, College of Computer Science & Information Technology, Latur.
- Participated in “Workshop on Interdisplinary Nanoscience 26th Feb.2012”organized by Swami Ramanand Teerth Marathwada University, Nanded.
- Active participation in “Technical exhibition (Biotech open house)2010” organized by MGM College of CS & IT, Nanded.
- Active participation in “Technical exhibition (Biotech open house) 2011” organized by MGM College of CS & IT, Nanded.
- Training Programmed : Biofertilizers & Biopesticides,Mitcon, Biotechnology & Pharmaceutical Centre,Pune.
- Visited to IBAB, Banglore.
- Visited to C-Camp, Banglore.
Project Name No.of Team Member
“Sequence analysis & Phylogenetic prediction of HBB gene” 1
Computer Literacy :
- Basic knowledge of Computers-MS-Word, MS-Excel, MS-Power Point.
- Other skill : MS-CIT, photoshop, Typing English40, Marathi30.
Declaration :
Above all the information is true best of my knowledge no extra information is given
Without any Certificate.
Date : - Kadam Smita Bapurao.
Place : - Nanded.

[Guest]

Is there any vacancy in pimpri chinchwad? I am working as a medical representative for the last 9 years. My email id ajilaraitheshATgmail.com. Raithesh ajila.dehuroad pune.