Alembic Ltd Pharma Baroda Vadodara : Regulatory Affairs

[Admin]

Post : Executive/Sr. Executive - Regulatory Affairs
Code : AV-RA
Department : Regulatory Affairs
Qualification : M.Sc.
Location : Vadodara
Experience : 3 to 8 years

Profile : Preparation and submission of dossier as per CTD format. Coordination with R&D, QA, QC & production for regulatory requirements for dossier submission and approval. Liaison with clients / local licensees, regulatory authorities. Responsible for preparation of variation and renewal documents.

Apply here:
http://www.alembic-india.com/openings.asp

Alembic Limited
Alembic Road,
Vadodara - 390 003.
Gujarat
INDIA.

ISO-9002 and ISO-14001 certified Asia's most respected integrated pharmaceutical company with manufacturing practices and facilities that conform to WHO-GMP guidelines, Alembic is in the business of improving the quality of life and healthcare in over 75 countries around the world.

We possess capabilities for preparing ANDA in eCTD , Technical Dossiers and Drug Master Files (DMFs) for a range of our products. Our facilities are constantly upgraded to comply with European and US Regulatory inspections, making us strategically poised to enter the regulated markets.Our facilities have been successfully audited by US-FDA and European Agencies. We have filed and received approval of some of our ANDAs and COS from respective Regulatory agencies.

[Guest]

DAVE VARUN B
E-MAIL :
varundave_niraj AT yahoo.in

OBJECTIVE :
To play a successful & critical role by providing value addition to the company with my structured learning, understanding and analytical skills.
EDUCATIONAL QUALIFICATION :

10th STANDARD (Mar-2000)
Sayaji High School, Vadodara
Gujarat Secondary Education Board
Percentage of mark – 71%
12th STANDARD (Mar-2002)
Sayaji High School, Vadodara
Gujarat Higher Secondary Education Board
Percentage of mark – 73%
B.Com [Commerce] (May-2005)
M S University, Vadodara
Percentage of mark – 56%
Industrial Purchasing & Material Management(IPMM)
(2010-2011)
Adult Education & Evening Course, M S University, Vadodara
Result Pending

TECHNICAL QUALIFICATION :
MS Office
Shah Computer Classes
Accounting Software- Tally
Tally Academy

C Programming
Aptech Computer Classes
C# Programming
Aptech Computer Class
LANGUAGE KNOWN :
English, Hindi & Gujarati
HOBBIES :
- Music
- Traveling
- Driving
- Surfing
WORK EXPERIENCE :
Worked with Jupiter Road Transport Services
Designation : Account and Office Assistant
Duration : May 2005 - Dec 2008.
Working with Baroda Equipment and Vessels Pvt. Ltd. (BEVPL)
Designation : Documents Controller
Duration : June 2009 to April 2010.
Working with Daniel Measurement Solution Pvt. Ltd. (DMSPL)
Designation : Documents Controller
Duration : May 2010 to till date.
CURRENT JOB PROFILE :
Keep record of Library (Like ASME Books, IBR, International Standard etc.)
Register & give coding to every technical document like drawings, material requisition, QCP, List of Qualified Welders, WPS, and Painting Procedures etc. according to revision.
Maintain day to day accounting works, voucher entries, bank reconciliation, payments to vendors, etc.
Update Contract Administration system.
Keep in touch with clients for revised technical documents.
Receiving and preparing time sheet of man power.
Coordinating with the project staff and organization as a whole.
Controlling and holding all documents.
Custodian of projects records from enquiry stage to archive.

[Guest]

CURRICULUM VITAE

ATUL ASTHANA
Email ID : asthana25 AT rediffmail.com
Career Objective :
A challenging position in a professional organization, where I would enhance my skills and its strength in conjuction with company’s objective..
Previous Experience :
IPCA Laboratories Limited, Ratlam (M.P.) as an Executive in Quality Assurance department since Sep. 2001 to 5th Nov.2009.
Present Experience :
Presently working in Alembic Ltd., Vadodara as a Sr. Executive in Quality Assurance department from 12th Nov.2009 to till date.

Job Skill & Personal Strength :
- OOS Investigation & review of CAPA
- OOT investigation & compilation of related documents and closing.
- To Monitor the Shelf Life of API based on Stability Data (Quarterly Review).
- Return goods, inspection & release activities.
- Customer’s Queries and their Responses.
- Samples submitted for Registration Purpose.
- Review of Technology Transfer documents.
- Review of Master Production and Control Record.
- To Conduct the Vendor’s Audit and handling of Vendor Documents.
- Preparation of SOPs.
- Handling of Market Complaints Activities including investigation of the complaints and their Corrective & Preventive Action
- Awareness about Change Control Proposal and Deviation’s
- Handling of Annual Product Quality Review.

Training Program Attended :
- Training of ICH Q7 GMP guideline for Active Pharmaceutical Ingredients.
- Training of Total Quality Management (TQM).
- 3 days Training on CGMP conducted by Mr. C.K.Moorthy,Hyderabad
Educational Qualification
- Have acquired M.Sc from Vikram University, Ujjain in the year 2000.
- Have acquired P.G.Diploma in Marketing Management from Vikram University, Ujjain in the year 1998.
- Have acquired B.Sc. from Vikram University,Ujjain in the year 1995
- Have acquired H.SC. from Vikram University,Ujjain in the year 1992
Computer skills :
M S Word, M S Excel, M S Power Point, Working Knowledge of Internet.

[Guest]

JIGME WANGMO
E-mail : jigwang2002 AT gmail.com
CAREER OBJECTIVE :
- Looking forward for a challenging job in Pharmaceutical organization from where I can learn practically the knowledge I came across during my graduation and would like to experience the production management. As education has no end, I will always like to learn more and more, to get closer to perfection.
SUMMARY :
- Skill in the use of computers, preferably in a PC, Windows-based operating environment.
- Operates as a member of the office's management team.
- Have worked extended hours as needed and be on call.
- Proven ability to work under tight deadlines.
- Positive team player attitude.
- Not afraid to ask questions in order to clarify ambiguous instructions.
- Motivated, flexible and a fast learner.
EDUCATION :
M. S. UNIVERSITY 2005 to 2009
B.PHARMACY - First Class (64.4%)

HSC - C.B.S.E - First Class (61.29%) June 2005
SSC - C.B.S.E - Distinction (70.4%) May 2003
TECHNICAL SKILLS :
- Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Internet
- Typing Speed – 40 WPM.
EXTRA-CURRICULAR ACTIVITIES :
- Participated in Aushadham (product launching), an event of Technotron at FOOTPRINTS 2008
- Have attended Tibetan women leadership program 2007
- Served as joint secretary of REGIONAL TIBETAN YOUTH CONGRESS from Feb 2008 to Feb 2009
- Have been board member for <Village Update> school magazine in English in year 2003

PROFESSIONAL EXPERIENCE :
KEYSTROKEPRO INDIA PVT. LTD. Sept 2009 – April 2011
Medical Transcriptionist
KeyStroke Pro is now the acknowledged leader in Legal Transcription and Medical Transcription, providing services for some of the largest and best known organizations in the UK and the US. Keystroke Pro are certified to ISO/IEC 27001 :2005 - Information Security Systems and we meet the US Health Insurance Portability and Accountability Act (HIPPA) requirements and guarantee American Association of Medical transcription (AAMT) defined 98% accuracy.
Responsibilities :
- Performing document typing and formatting functions according to an established criteria or format.
- Transcribing the spoken word of the patient's care information into a written, easily readable form.
- Correcting spelling of all terms and words as per according to British English to UK Client and American English to American client, (occasionally) correcting medical terminology or dictation errors.
ETECH INC June 2009 – Aug 2009
Tele Sales Representator for AT&T Lead Generation
Etech, Inc. is a leading provider of business process solutions including customer interaction and quality assurance services, development and value-added services. Headquartered in Nacogdoches, Texas, Etech employs over 2,300 employees. Etech's model of partnering with other growing enterprises to enhance their customer presentation and interaction, has earned Etech the business of several Fortune 500 companies. With each new year, Etech expands the industry to assist growing businesses in new and innovative ways. Currently, Etech serves in Customer Interaction Services, Quality Assurance (EMS), Development Services, Collegiate Services, Receivable Management Services, Value-Added Services areas.
Responsibilities :
- Process inbound web site inquiries and convert them to qualified leads.
- Actively make outbound calls to find qualified leads. This is equally critical for success.
- Update prospect database with activities and any new contact names.
- Cultivate prospects till they become leads.
- Work with sales to identify target companies and generate qualified leads within those accounts.

[Guest]

DISCIPLINE :
BECHLOR OF PHARMACY

E-MAIL ID :
mayurshine89 AT yahoo.com

STATEMENT OF PURPOSE
Seeking a position to utilize my skills and abilities with the organization that offers professional growth while being resourceful, innovative and flexible and be a part and partial of organization's growth.
ACADEMIC RECORD
- Completed B.Pharm with 1st CLASS from K.V.VIRANI Institute of Pharmacy Education & Research Centre, Savarkundala, Gujarat.
Examination Year Percentage University/Board
B.Pharm 2010 60.98 Saurashtra University
H.S.C. 2006 70.80 G.H.S.E.B
S.S.C. 2004 78.00 G.S.E.B
VISITED :
1. I have taken industrial visit at RELISH PHARMA LTD COMPANY.
PROJECTS UNDERTAKEN :
A project on “PATIENT COUNCELLING” During study at
village ramgadh.
INDUSTRIAL TRANING
I have been completed my industrial training in servey PHARMACEUTICAL Company, At Santej,Ahmedabad for three month.
EXPERIENCE
I was working in WEST-COAST PHARMACEUTICAL
WORKS LTD COMPANY AT GOTA AHMEDABAD FROM MAY 2010 to April 2011
At present days I am working in claris lifescience ltd. At chacharavadi,vasana from may 2011 to continue..

DESIGNATION
As a Production officer.
INTERESTS AND HOBBIES :
Surf Social Networking sites
Playing Cricket,
Bike riding
Traveling

JOB RESPONSIBILTY IN TABLET DEPARTMENT
- During Raw Material issue, I am check T.R.NO & Q.C Approved label that hold on active material & inactive material drum & check weight on calibrated weight balance
- Cleaning record maintain.
- According sop work done.
- BMR copy maintains at online and equipment log sheet maintain.
- In process-granulation, cross checking of raw material done on calibrated weight balance.
- All during granulation procedure like shifting, mixing, binding, drying, milling, lubrication, I routine check all checkpoint.
- Reprocess handling.
- Co- operates with auditors.
- At sometimes I am handling compression work & check tablets parameters like friability, D.T,weight variation, hardness & thickness.
- I am also handle Quarantine room and its record maintain.

JOB RESPONSIBILITY IN PARANTERAL DEPARTMENT.
- To handle sterilization.
FIELD INTEREST :
- Production officer.
- Research & Development
- Quality Assurance officer.
PERSONAL STRENGTHS :
- Positive to my work
- Accept my faults
- Try to something new in my work every time
- Transparent

[Guest]

Bhavika D Zala
bhavikadzala AT yahoo.com
My education profile is M.Sc. in Microbiology and I possess four years of experience in QC Microbiology. At present I am working as Assistant Manager Operation in Osaka pharmaceutical Pvt. Ltd. (Formulation Plant) located in Sankarda (Vadodara), Gujarat India. I am handling the operation of all departments starting from new order to dispatching of goods. I also possess proficiency in microbial culture handling, associated assays and regulating the environment of microbiological laboratory. I have actively worked in data collection, analysis and documentation of experiments set up in laboratory conditions. I have also been involved in process modification, optimization for microbial assessments, environmental monitoring and validation of various equipments to give more yields, and / or use less resources and time. Additionally, I possess knowledge about the working of QA department.
Objective
Seeking a position in an esteemed organization which gives me an opportunity to improve my knowledge and enhance my skills in the field of Pharmaceutical industries and be a part of the team that excels towards the growth of organization and mine.
Approval
- FDA, Gandhinagar approved Microbiologist.
Academic record
- S.S.C.; 71 %; (C.B.S.E, Central Board of Secondary Education); 1997.
- H.S.C.; 60 %; (C.B.S.E, Central Board of Secondary Education); 2000.
- B.Sc.; 59 %; Microbiology; Sardar Patel University, Gujarat India; 2003.
- M.Sc.; 80 %; Microbiology, IASE Deemed University, Rajasthan India; 2005.
Job profile
- Handling of all the departments from generating purchase order to the dispatch of products and related documents.
- Evaluating microbial limits in API & Finished products.
- Microbial and chemical analysis of water.
- Analysis of bacterial endotoxins.
- Environmental monitoring.
- Data evaluation, documentation and records preparation.
- Preparing & maintaining and review of SOP's, Operational Protocol etc.
- Operation, Calibration and validation of Microbiology laboratory instrument.
- Involved with colleagues during regular audits.
- Active support for general administration, purchase, and maintenance in the department.
Some projects
- Alembic Research Centre Bioarc, Vadodara Gujarat; 2005
Minimum inhibitory concentration of antibiotics against in-house micro-organisms
- M. J. Pharmaceuticals (Sun Pharmaceuticals), Halol; 2005
Evaluation of Sanitization solutions against in-house micro-organisms
Skill set
Microbiological techniques and analysis :
- Microbial culture handling, identification, culturing, maintenance and associated microbiological assays to evaluate micro-organisms in various pharmaceutical samples e.g. MPN test, acid production, endotoxin production test etc.
- Microbiological analysis of water e.g. microbial limit test of water. Growth promotion and antimicrobial effective test.
- Environmental monitoring using volumetric sampling and settled plate method.
- Antibiotic based assays.
Chemical analysis :
- Chemical analysis of water e.g. pH, conductivity measurement, total hardness using titration, total dissolve solid using evaporation method, total organic carbon (TOC) using TOC analyzer.
- Biological oxygen demand (BOD) and Chemical oxygen demand (COD) of waste water effluent.
- Identification of sample constituents using Gas Chromatography.
QA exposure :
- Preparation of batch manufacturing record (BMR).
- Standard operating procedure for operation and cleaning of plant equipment.
- Preparation of specification and standard testing procedure (STP).
- Controlling, issue and retrieval of the documents.
- To fill the customer questionnaires and sending to the market department.
- Handling and closing of change controls and deviations with supporting documents.
- Worked as team member during several customer audits.
- Actively participated in regulatory audits like USFDA, KFDA & EDQM.
- Online monitoring of shop floor activities related to production department.
- Routine QA function, i.e. plant audit, BMR issuance, review and archival.
- Issuance of controlled product labels.
- Handling of dispatch activity.
Computer Proficiency :
- Proficient in MS-Windows and all its associated applications including MS-office and MS-excel and adobe acrobat.
- Online documentation of data and basic knowledge of working over internet.
Employment history
- Present Job Osaka Pharmaceuticals Pvt. Ltd., Vadodara, Gujarat India September 2011 to till date.
- Zyduscadila API/Bulk Drug Plant, Ankleshwar, Gujarat India
August 2010 to March 2011
Senior Chemist
- Osaka Pharmaceuticals Pvt. Ltd., Vadodara, Gujarat India
October 2009 to March 2010
Senior Microbiologist
- Bharat Parenterals Pvt. Ltd., Vadodara, Gujarat India
September 2008 to September 2009
Microbiologist
- Choksi Laboratory Pvt. Ltd., Vadodara, Gujarat India
September 2006 to August 2008
Microbiologist

[Guest]

CURRICULAM VITAE
Megha J. Patel
E-mail Id : mpatel.megha AT gmail.com
mpatel_megha AT yahoo.co.in
.
OBJECTIVES
- To be employed in an organization, which provides me with a challenging work atmosphere and allows me to grow both professionally, as well as, individually.

EDUCATIONAL QUALIFICATION
Year Degree College/School University/ Board Percentage
May 2012 M.pharm Forth semester Parul Institute of Pharmacy, Waghodiya , Baroda. GTU Continue DEC 2011
M.pharm Third semester Parul Institute of Pharmacy, Waghodiya , Baroda. GTU 8.57SPI JUNE 2011
M.pharm Second semester Parul Institute of Pharmacy, Waghodiya , Baroda. GTU 8.00SPI JAN 2011
M.pharm First semester Parul Institute of Pharmacy, Waghodiya , Baroda. GTU 8.00SPIMay 2010
Final B.Pharm Indukaka Ipcowala College Of Pharmacy ,New Vallabh Vidya Nagar. S.P.U 66.61% Mar 2006
H.S.C. Tapans Vidhyalaya,Baroda. G.H.S.E.B. 80.80% Mar-Apr 2004
S.S.C. Amity Highschool,Bharuch. G.S.E.B. 82.86%

COMPUTER SKILLS
Operating System :- MS office( MS word, Excel, Powerpoint,),, Handling Internet operating

INDUSTRIAL VISIT
- Zydus Cadila Healthcare LTD. ,Moraiya, Ahmedabad.
- Hikal LTD.,Panoli,Bharuch
- Vasu Healthcare LTD.,Vadodara

AREA OF INTEREST
- R&D Department , F&D Department, R.A. Department, Q.A. Department

EXTRA CURRICULAR ACTIVITIES
- Attended 2 Day National Conference on Advance in Drug Delivery System held by Parul Institute of Pharmacy, Sponcered by GTU on march 24th-25th 2012.
- Participated in Pharma Painting competition with Theme “Scope of Pharmacy” held at Parul Institute of Pharmacy on 16th February, 2012.
- Presented poster in Poster competition in Indo American Pharmaceutical Regulatory Symposium held at Nirma University on “Preparation And Evaluation Of Mucoadhesive Gel Containing Itraconazole Loaded Microcapsules” on 11th-13thNovember, 2011.
- Attended 2 Day National Conference on Particle Technology with Special Emphasis on Nanotechnology held at Parul Institute of Pharmacy, Vadodara on April 22nd-23rd 2011.
- Attended 2 days Short Term Training Program on Structural Elucidation of Organic Compounds Based on Spectroscopic Data held at Parul Institute of Pharmacy, Vadodara on 4th -5th October 2010.
- Attended One Day Seminar on HIV/AIDS AWARENESS on Friday 24th October, 2008.
- Attended 61st Indian Pharmaceutical Congress held at Nirma University,Ahmedabad from 11th-13th December,2009.

STRENGTH
- Always trying to be innovative and active in any pursuit.
- Good team worker & facilitator
- Self confident and self motivated.
- Honest
- Leadership

Strengths : My confidence, positive attitude and self-belief and adapting myself to any term or environment.

DECLARATION
- I hereby declare that all the particulars written above true to the best of my knowledge and belief.
Megha J. Patel

[Guest]

CURRICULAM – VITAE

E-Mail : hinsu_jindal AT yahoo.co.in
JINDAL HINSU
Objective
To utilize knowledge, experience and creativity to further the interests and needs of the organization that I serve in, and to contribute worthwhile in it’s Growth in the field of Automation.
About Me
I am a confident person with fine communication skills, possesses friendly nature, believe in team work, having positive attitude towards the responsibilities given, do work hard on the given assignment to attain maximum results, can work under stressful conditions for my employer for attaining results.
Work Experience
- Khodiyar Borewell in Durgapur West Bengal from July-October
- 2010 :- A project from Essar for oil and gas exploration as a Manager Providing guidelines and checking daily reports and work progress.
- Jyoti CNC & Automation from December 2010 :- As Assembly Supervisor checking time to time updates of work completion and planning material support for building of Machines.
Education
- Bachelor of Engineering in Mechanical Engineering from R.K. College of Engineering (Saurashtra University). (Batch 2010).(58%aggregate).
- Senior Secondary from Swami Vivekanand Gujarat Board of Secondary Education, Gujarat in year 2006.(56.60%).
- Secondary from RS Kalaria Gujarat Secondary Education, Gujarat in year 2004. (69.71%)
Technical Knowledge
- Auto-Cad
- Pro-E
Area Of Interest
- Power Plant
- Machine Designing
Technical Certification
- Pro-E and Auto Cad
Computer Proficiency
- Operating Systems :- MS-DOS, Windows.
- Tools :- Ms-Office
Projects
- Project on photovoltaic Air Conditioner of Car.
- Project on Air Motor.
Extra Curricular Activities
- National level certificate in Tenicoit
- Participate in various college and inter-college debate competition

[Guest]

RESUME
PANDYA HIMA VIPINCHANDRA.
Email : pandyahima88 AT gmail.com

OBJECTIVE
To work with growing organization with full devotion towards work with the help of my knowledge and abilities. To obtain a challenging position in an organization where I can contribute to the development of the organization along with individual development.
Strength Self-confident, Competitive attitude, Optimistic, Adaptive, Amiable
ACADEMIC CREDENTIALS
EXAMINATION BOARD/UNIVERSITY PERCENTAGE CLASS
M.PHARM-(Pharmaceutics)
Aggregate RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCE 76.14% Distinction
B.PHARM-Aggregate GUJARAT UNIVERSITY 61.4% 1stCLASS
H.S.C. GHSEB 86.6% Distinction
S.S.C GSEB 90.29% Distinction
TRAINING & PARTICIPATION
- Industrial training at Brij pharmaceuticals, Himmatnagar, Gujarat.
- Industrial training at linceon pharmaceuticals, Ahmadabad, Gujarat.
- National workshop on biostatistics and Research methodology. At Srinivas college of pharmacy, Mangalore.
- International pharmaceutical congress (IPC) 62nd , Manipal, Uddupi, Karnataka.
- National seminar on Challenges to face in pharmaceutical research. At Srinivas college of Pharmacy, Mangalore.
PAPER PUBLICATION
- I have submitted three papers in various international journals, Which Are entitled As follows,
1. Formulation development and evaluation of Doxophylline sustained release matrix tablet.
2. Preparation and evaluation of Niosomes containing Trihexyphenidyl.
3. Formulation and evaluation of microcapsules of Trihexyphenidyle hydrochloride by solvent evaporation method.
EXTRA CURRICULAR ACTIVITIES.
- Taken part in various cultural and technical events organized at our college as well as on other campuses.
- Taken part in various sports like badminton at sports days in all four years.
COMPUTER LITERACY
- Working knowledge : Windows 98/2000/XP/VISTA/windows 7
- Comfortable with Microsoft Office tools, Adobe Photoshop and internet utilities
DECLARATION
I hereby declare that the above mentioned information is true to the best of my knowledge.
(PANDYA HIMA)

[Unregistered]

Reema Pathak
E–Mail : pathak_reema90 AT yahoo.com

Personal Dossier :
Nationality : Indian
Date of Birth : 9th May, 1990
Marital Status : Single
Hobbies : Shopping, Music.
Languages known : English, Hindi, Gujarati
Strengths :Honesty, Positive approach, Hard Working.

Academic Credentials :
June 2013 M.Sc (Microbiology) from S.P University, V.V.Nagar with 65%
May 2011 B.Sc (Microbiology), S.P University, V.V.Nagar with 51%.
May 2008 H.S.C. (Science Stream ), GSEB, Gandhinagar with 56%.
June 2006 S.S.C, from GSEB, Gandhinagar with 76%.

Did desertation during 4th sem of MSc Microbiology on “IN VITRO SCREENING OF LOCALLU ISOLATED LACTIC ACID BACTERIA AND ITS PROBIOTICS ATTRIBUTES.”

IT Skills : Knowledge of MS Office and Internet

I hereby declare that, all the information provided above is factual and correct to the best of my knowledge and belief.

REEMA PATHAK

[Unregistered]

CHIRAG MODI
Email : chiragmodi3497 AT gmail.com

OBJECTIVE :
To work in a stimulating and challenging environment that would facilitate the maximum utilization and application of my broad skills and expertise in making a positive difference to the organization

AREA OF INTEREST :
Quality assurance
Pharmaceutical Regulatory affairs
Quality control
Research and Development.
Product Management Team / Product Development Team
Supply Chain Management

ACADEMIC RECORD :
Sr.No. Details School/College Board/ University Result Year
1. M.Pharm
(Regulatory affairs & Pharmaceutical Management) K.B Institute of Pharmaceutical Education & Research (KBIPER) Kadi Sarva Vishwavidyalay, Gandhinagar
Sem 1 : 7.24 SPI
Sem 2 : 7.86 SPI
Sem 3 : 7.80 SPI
Sem 4 : 7.76 SPI
Class : Distinction 2013
2 B.Pharm. Dharmaj Degree Pharmacy College, Anand Gujarat University, Ahemdabad 67.67% 2011
3 HSC Saradar Vinay Mandir Vidhyalaya ,Vadodara GS&HSEB, Gandhinagar 78% 2007
4 SSC Nutan Vidhyalaya, Vadodara GSEB, Gandhinagar 89.86% 2005

DISSERTATION WORK (M.PHARM) :
Dissertation work of M.Pharm (Pharmaceutical Management & Regulatory Affairs) is carrying out at Osaka Pharmaceutical Pvt. Ltd., Baroda under supervision of Mrs. Lopaben Gandhi, Head Of Department of Regulatory Affairs and college guide Prof.K.M.Patel, H.O.D.,
Pharmaceutical Management & Regulatory Affairs, KBIPER, Kadi Sarva Viswavidyalaya University, Gandhinagar, Gujarat.
TOPIC : To develop of a Pramipexole tablet and to prepare a registration dossier of the same for south Africa in CTD format as per new guideline.

EXTERNAL COURSE/TRAINING :
Sr.No. Details Institute / Company Year
1. PG Diploma in Patent Law (Distant Learning) National Academy of Legal Education and Research (NALSAR), Hyderabad 2012 (Perusing)
2. Industrial Training as part of B.Pharm. (1) Alembic Limited Alembic Road, Vadodara, Gujarat
(2) Vital Pvt. Ltd. G.I.D.C., Dist. Anand, Gujarat 2010-11
3. Indusrial Training as part of M.Pharm. Osaka Pharmaceutical Pvt. Ltd. National Highway NO. 8, Sankarda, Vadodara, Gujarat 2012-2013 (6 Months)
4. QA/RA Executive Mil Laboratories Pvt. Ltd. Savli-GIDC, Manjusar, Vadodara. May 2013till now

ACHIEVEMENT :
Qualified GPAT 2011 with 1570 AIR
Secured A Grade in DL-101 General course on Intellectual Property Rights of WIPO authorized certificate Examination
Secured 1st position in Scientific Poster Competition at State Level Apocalypse-2009
Secured 2nd position in Scientific Model Competition at National Level Pharmafest-2010

PROFESSIONAL SKILLS :
Skills in reviewing and compliance check of dossiers in CTD. Review, and Compilation of Chemistry Manufacture Control (CMC) part and formatting in CTD Good knowledge on ICH, EMEA, FDA and other regulatory guidelines.
PREPARING AND SUBMISSION OF REGULATORY DOCUMENTS, MAKING DOSSIERS, COMPLYING REGULATORY REQUIREMENTS, DOCUMENTATION
BMR,MFR,Q.C TESTING REVIEW, Line Clearance, WHO GMP and FDA audits faced, Gujarat FDCAProduct approval, Licence renewal, T.P. Approval etc.

CONFERENCE ATTENDED :
“Indo American Pharmaceutical Regulatory Symposium 2011” held at Institute Of Pharmacy, Nirma University, Ahmedabad.
“Workshop On Drug Regulatory Affairs – 2012” held at Ramanbhai Patel College Of Pharmacy, CHARUSAT, Changa, Anand.
“APA International Congress On Advances In Human Health Care Systems 2012” held by Health Care India, Delhi
“ICMR sponsored National Seminar on role of " Lab. Sci. Animals in Clinical Research" held at KBIPER,Gandhinagar.
“DIA Conference on CMC :Converting Science in Regulatory Submission” held at Ahemdabad

EXTRA-CURRICULAR ACTIVITIES :
Event Student Coordinator in KSV Impulse at KBIPER,Gandhinagar.
Co-ordinated the various cultural and technical events during academics.
Participated in Pharma Visual Aid Designing & Questionnaire Designing at KBIPER, Gandhinagar.
Participated in Pharma Marketing competition at IICP, New V.V.Nagar
Participated in I Raga at KBIPER , Gandhinagar.
Student member of DIA (Drug Information Association)

SPECIAL SKILLS :
Ability to adopt New Technologies soon
Ability to communicate effectively with the team members.
Capacity to work in team or individually.
Convincing power

COMPUTER SKILLS :
Tools : MS Office
Operating Systems : Windows XP/Vista/7

PERSONAL DETAILS :
Date of Birth : 14th October, 1989
Languages Known : English, Hindi, Gujarati

I hereby declare that the above-mentioned information is true to the best of my knowledge.

Place : VADODARA
CHIRAG MODI Date : 30/07/13

[Unregistered]

BHAIYALAL PANDEY
E-Mail :bl_pandey10 AT yahoo.co.in
bhaiyalal_pandey AT yahoo.com

Secure a position with a well-established organization with a stable environment that will lead to a lasting relationship in the field of Pharmaceutical

PROFESSIONAL SNAPSHOT :
** A skilled and result oriented professional with nearly 10 years of experience in the field of Pharmaceutical.
** Currently associated with M/S Cipla Ltd., Indore as a Section Head/Reviewer.
** Possess knowledge of testing and documentation of drug and bulk intermediates as per the, ICH, WHO Guidelines.
** Ability in learning new concepts quickly and communicating ideas effectively.
** Carries a positive attitude, enthusiastic and a firm believer of team work.

CAREER FORTE :
M/S Cipla Ltd., Indore (M.P.) Section Head/Reviewer Jun 2010 to continue
M/S Ipca labs Ltd., Ratlam (M.P.) QC officer/Reviewer Feb 2007 to Jun 2010
M/S Parenteral Drugs (India) Ltd., Indore (M.P.) QC officer Aug. 2005 to Feb 2007
M/S : Indo lab Ltd.Rau Pigdamber Indore (M.P.) QC officer Jun 2004 to Aug 2005 M/S Emerson lab Ltd.Pithampur Dhar (M.P.) QC officer Jul2003 to Jun 2004

Responsibilities
** Accountable for developing and implementing CGMP / CGLP system as per various regulatory requirements.
** Responsible for handling maintenance of analytical instruments.
** Reviewing chromatographic data with TDS.
** Evaluating raw material and finish products of pharmaceuticals products.
** Involving in installation Qualification, Operation, Qualification and Performance.
** Maintaining all laboratories instrument and their records.
** Preparing Standard testing procedure, General test procedure, & Specification of raw materials, finished products.
** Planning, internal audit & coordinating with the management.
** Daly work allocation.
** Responsible for overall quality performance of process and products.
** Developing new method for interfering ingredients and impurities.
** Review of analytical data submission to Regulatory for ANDA Submission.
** Handling of Incidences, OOS and OOT and their Tracking.
** Review of Change control of QC dept.
** Audit Faced like, US-FDA, MCC, INVISA, MHRA, TGA
** QCMS (Quality control management system

EDUCATION :
** M.Sc. Chemistry
** M. Sc Physics
** M. Phil

HANDLING HPLC’s AND THEIR MAINENANCE& CALIBRATION :
** AGILENT 1200&1260 CHROMELION SOFTWARE (online Calculation)
** DIANOX ULTIMATE 3000 CHROMELION SOFTWARE (online Calculation)
** SHIMADZU CHROMELION SOFTWARE, LC SOLUTION & CLASS VP
** WATERS EMPOWER
** PERKIN ELEMER TOTAL CHROM NAVIGATER
** ELITE EZ CHROM ELITE
** MERK D-7000 HSM ADMISITRATOR
** PC CHROMQUEST 4.1 &TSP
** SERVEYER CHROMQUEST

HANDLING OTHER INSTUMENT THEIR CALIBRATION
** U.V. /VIS SPECTROPHOTOMETER (SHIMADZU –1601&1700)
** DISSOLUTION TEST APPARATUS.
** KARLFISHER TITRATOR (K.F.T.)
** POLARIMETER.
** CONDUCTIVITY METER.
** MELTIG POINT APPARATUS.
** DISTINTEGRATION TEST APPARATUS

COMPUTER KNOWLEDGE :
** FUNDAMENTAL COMPUTER.
** MS-WORD, MS-EXCEL.
** USES OF MULTIMEDIA, INTERNET, E-MAIL CONCEPT.

PERSONAL SNIPPETS :
Name : Bhaiyalal pandey
Father's Name : Shri Gayatri Prasad Pandey
Date of Birth : 08/08/1978
Marital Status : Married
Blood group : O positive
Nationality : Indian
Language Known : Hindi & English

HOBBIES :
Playing cricket, Listening Music, Reading & Writing

DECLARATION :
I have to declare that all the above information given is true and best to that of my knowledge.
Date : / /
Place : Indore
(BHAIYALAL PANDEY)