www.bdrpharma.com BDR Pharmaceuticals Internaional Pvt Ltd Ahmedabad, Mumbai : REGULATORY AFFAIRS

[Admin]

BDR Pharmaceuticals Internaional Pvt Ltd
http://www.bdrpharma.com
bdrpharma.com

Keywords: REGULATORY AFFAIRS, pharma, REGULATORY

Designation: REGULATORY AFFAIRS (1 No.)
Experience: 7 - 12 Years
Location: Ahmedabad, Mumbai
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Healthcare, Medical, R&D

Job Description
Preparation of Dossiers in CTD Format for Semi-regulated markets and Europe

Desired Candidate Profile
B.Pharm/M.Pharm with 5 to 15 years relevant experience. Age between 30 and 45 years. Ladies preferred.

Company Profile
Manufacturing and export of APIs and Finished Formulations

Address:
BDR Pharmaceuticals Internaional Pvt Ltd
4th Floor, 407- 408, Sharad Chamber
New Marine Lines, Churchgate
Mumbai,Maharashtra,INDIA 400020

Email Address: bdrpharma@vsnl.net

[Guest-IJT]

Name : jitendra yadav
Email : y2jiten AT gmail.com
Designation / Skillset : Regulatory affairs
An application for Regulatory affairs

Resume :

AREA OF INTRREST : REGULATORY AFFAIRS
I have thorough knowledge of DOSSIER, DMF, ACTD, CTD,ENVISA, ANDA, MCC…..etc

Academic Profile
Maharashtra State Board
Courses School/College Percentage
X I.D.U.B.S. Hindi High School , Bhandup 79.60
XII U.B.S. Junier Collage , Bhandup 66.67
Bachelor of Pharmacy
Dr.L.H.Hiranandani collage of Pharmacy UNR-3 Mumbai University
Year Class
F.Y.BPharm Ist Class
S.Y.BPharm Ist Class
T.Y.BPharm Ist Class
Final Year ist class(65%)
EXPERIENCE :
- Seven Month Experience in Pharmaceutical Marketing in Abbott Healthcare Pvt Ltd.
ADDITIONAL ACTIVITIES :
INTERNSHIP :
- Have undergone through in plant Industrial Training in PRERNA PHARMA INDUSTRIES PVT. LTD.

Declaration-
I the undersigned hereby declare that the information given by me is true to the best of my knowledge & belief.
Place : -Mumbai Jitendra M. Yadav
Date : - Name and signature
-------------------------------------------------------
More Information about this submission and submitter :-
___________________________________________________
Submission ID : 4189115
Date & Time : 30th May 2011 5:55 AM (UTC)
IP Address : 120.61.46.58
Browser Info : Mozilla/5.0 (Windows NT 5.1) AppleWebKit/534.24 (KHTML, like Gecko) Chrome/11.0.696.71 Safari/534.24
Predicted Country []: India

[Guest]

PATEL JIGNESHKUMAR ARVINDBHAI
jignesh1423 AT yahoo.co.in

OBJECTIVE
Seeking a challenging and rewarding opportunity with an organization of repute which recognizes and utilizes my true potential, nurturing my analytical & technical skills in the field of Social Work/ HR Management

- Accented with the latest trends and techniques of the field, having an inborn quantitative aptitude & determined to carve a successful and satisfying career in the industry.
- Interest in managing projects including financial aspects, undertaking research work & networking with different stakeholders like businesses, community, NGOs and Government Organizations / Agencies
- Willingness to learn to keep abreast of new developments in the field.
- Outstanding communication skills, verbal as well as written coupled with exceptional presentation skills with the ability to perform above expectations.

EDUCATIONAL CREDENTIALS
MSW with HR Specialization
Ganpat University, Kherva

B.A. 2009
H.N.G.U; 65.00%

H.S.C. 2005
G.S.H.E.B; 65.00%

S.S.C. 2003
G.S.H.E.B.; 59.29%

Technical Skills
MS Office, Windows and Internet Applications

Projects Undertaken DURING MSW
- First Sem : A study on “Socio economical condition of S.H.G members”
- Second Sem : A study on satisfaction level of workers in terms of wages, works and facilities provided under Mahatma Gandhi National Rural employment Guarantee Act,
- Third Sem : A study on Factors leading Job Absenteeism
- Forth Sem : A study on Factors of Attrition and Retention

Experience :
I am working as a HR TRAINEE in APOLLO INFRATECH PVT. LTD, at Rajpur.
Accountability : -
- Maintain day to day employees attendance record
- Maintain employees leave records
- Maintain employees personal records
- Joining formalities of new joining employees
- Monthly Salary and wage administration
- Compliances under Provident fund act
- Return of Professional tax
- General administration

Date of Birth : 23rd December 1987
Hobbies : Traveling, Playing with computer
Language Known : English, Hindi, Gujarati
Reference will be available on request.


Thanking You,
With Regards,

Jignesh A. Patel

[palak rai]

CURRICULUM_VITAE
Objectives
To work in challenging atmosphere which provides commensurate opportunities for learning and growth.

Name PALAK RAI
Email pari_6721 AT yahoo.com , palak_6721 AT rediff.com
Academic Qualifications
Course Year Board/University
X 1997 C.B.S.E Delhi
X+II (Medical) 1999 C.B.S.E Delhi
B.Sc. (Industrial Microbiology) 2003 Kurukshetra University
M.Sc.(Industrial Chemistry, Pharmaceuticals) 2005. Kurukshetra University

In Course Seminars Delievered
Human defence systems
Role of Anti metabolites as Neoplastic Agents.
Technical Qualifications
Basic computer skills, MS-Word, Excel & Internet search operations (regarding research).
In Course Project Profile
1.
Title Under guidance of Venue Duration
Evaluation of milk samples obtained by hand milking and machine milking by Microbiological methods. Dr Sanjeev Kumar Tomar &
Dr Sanjeev Anand (Senior Scientists). NATIONAL DAIRY RESERCH INSTITUTE, Karnal One month
2.
Title Under guidance of Venue Duration
Concepts of Quality Control and Quality Assurance. Dr Basudev Sanyal (QC Manager). Wings Pharmaceuticals Pvt. Ltd, D-6, Udyog Nagar Ind. Area. New Delhi. Three month

On hand jobs
1. Worked with PHARMAFILIATES ANALYTICS AND SYNTHETICS PVT. LTD. Chandigarh as Executive Quality Assurance/ Regulatory Affairs, From November 2005 to march 2007.
2. Worked with SYSMEX INDIA P LTD as Senior Executive Quality Control, From march 2007 till march 2011.
Job description
Testing of Raw Materials & Finished Products using Chemical and Sophisticated instruments like HPLC, GC etc and maintaining Log Books for keeping the record of usage time of each machine.
In-process control of various medicinal products at processing as well as final stage which included pH metry, mass tests etc. In case of medicines there is assay for each ingredient (chemical), this also includes several techniques from chromatography to spectral analysis.
-
Assistance in Preparation of Drug Master File and Site Master File For Europe and US.
-
Preparation of Standard Operating Procedures, Standard Testing Procedures, Instruction Manuals etc for various departments and their revision at regular intervals.
Job responsibilities (previous employer)
1. Quality control of production processes
- QC Inspection for in-process of the reagent and its final QC.
- Giving appropriate instruction to production staff to maintain stable and high quality of production processes and product.
- Filling up and checking production check list and all Quality Assurance documents for production.
- Preparing/improving the standard quality instruction manual of production operation if in case of trouble shooting or for quality improvement.
- Regular monitoring of manufacturing rooms (temperature, humidity etc) and hygienic conditions of workers in the place. In case of any problem should consult production manager or production line supervisor.
2. Stock control of QC materials
- Preparing and keeping necessary reagents (required for the QC) stock inventory, which should be reported monthly to the manager Accounts.
- Storing of the QC Instruments, raw materials, standard reagents and other QC materials under instructed environment.
3. Maintaining QC Instruments
- Performing or requesting periodic maintainence of QC Instruments in accordance with the instruction manual specified by the supplier and keeping its records.
- Maintain good contacts with the suppliers in order to delay trouble shooting.
- On-the-job (OTJ) training of the QC Instruments for the new staff.
4. ISO QMS
- Establish ISO documents like Quality procedure(QP), Work Instruction (WI) etc as and when required.
- Conduct an Internal Quality Audit (IQA) whenever necessary.
Short Project Report
Synthesis of Acridone Intermediate.
-
Study of Photochemistry on Benzophenone.
-
Strengths

- Ability to work under pressure & meet deadlines.
- Willingness to work with diverse people
- A good communicator.
- A result oriented person
- A fast & inquisitive learner.
- A good listener.
- A data oriented person
- Analytical Bent of Mind & Quest for Research & Analysis
- Enthusiastic with positive attitude.
Importants

- FDA Certified Analytical chemist.
- ISO 9001 Certified Auditor.
- Member of INDIAN PHARMACEUTICAL ASSOCIATION
Done advanced course in GAS CHROMATOGRAPHY in Industrial Chemistry (2 weeks full time 8.11.2010-19.11.2010), under guidance of Dr R. R. Patole at ATI, Sion , Mumbai.
PERSONAL STATEMENT
I have been able to achieve a balance between my academic performance and extra curricular activities. I am looking forward to a career in your organization that will provide me with avenues for continuous learning and development through exposure to different situations, a career that will provide sufficient challenges towards my professional development. I believe that my education and extra curricular achievements, coupled with my commitment and willingness to work hard will help me overcome challenges and attain success in my future endeavors.

Date
Place Mumbai
Given annexure-1, indicates a brief of syllabus of MSc Industrial Chemistry specialization in Pharmaceuticals, this is treated equivalent to MPharma.

ANNEXURE -1
M.Sc. Industrial Chemistry with Specialization in Pharmaceuticals
Outline of the Course

1. Organic Chemistry
Organic Reaction Mechanism, Organic Photochemistry, Pericyclic Reactions,
Advanced Stereochemistry, Strategies of Organic Synthesis, Use of Newer
Reagents in Organic Chemistry, Chemistry of Natural products.

2. Bio- Inorganic Chemistry
Metals, Metal Chelates and Organometallics in medicines, Chemical toxicology.

3. Bio- Physical Chemistry
Basic concepts of Chemical thermodynamics, Kinetics, Surface Phenomenon
and Catalysis as applied to life processes.

4. Analytical Techniques
Spectroscopy (Theory and application of UV, IR, 1HNMR, 13 CNMR & Mass in determination of structure of organic compounds), pH Metry, Conductometry, Polarimetry, Flame Photometry, Nephalometry, Turbidimetry, Chromatographic Techniques ( Paper, TLC, Column, HPLC, Gas Chromatography).

5. Introduction to Chemical Engineering
Mass Transfer, Fluid Flow, Reactors, Heat Exchangers, Distillation, Filtration, Crystallization, Unit Processes.
6. Pharmaceutical Technology and Management
Formulation, Evaluation and Quality Control (Tablets, Capsules, Emulsions, Suspensions and Injectables), Sterilization, Impurity Profile, Cost Estimation, Patents, GATT, WTO, GLP, GMP, CGMP, IPR.
7. Pharmaceutical Chemistry (Two Special Papers)
Drug Design and Synthesis, Dosage forms, Mode of Action and Medicinal uses of various classes of Drugs. Pharmacological basis of Therapeutics, Pharmacokinetics, Pharmacodynamics, Receptors, Metabolism of various classes of drugs.
8. Laboratory work
Synthesis of Drug Intermediates, Use of Chemical and Spectroscopic Control Techniques in structural elucidation of organic compounds, Extraction of natural products which are of medicinal importance.
9. Project work
Twelve weeks of on-the-job training/ research project in R&D wing of pharmaceutical industry of repute and/ or research laboratories of National Institutes, immediately after completion of M.Sc. ((Final) Examination.
Respected sir,
All the information given here are true, besides I would like to add to it that I have a wide variety of experience in pharmaceutical industry, diagnostic industry, analytical laboratory as well as teaching to students of class X, X+I, X+II (biology and chemistry) in a reputed public school for about six months.
I believe in working hard and that too with honesty.
I have experience of five years in Quality section. But I can do equally good in R&D also.
Hope you will consider my cv, for your reputed organization .