www.ajantapharma.com Ajanta Pharma Ltd Mumbai : Drug Regulatory Affairs Officer

[mskavi]

Ajanta Pharma Ltd

Keywords: DRA, Dossier compilation, Regulated Markets, EU, CTD Format, DMF

Company Profile
Incorporated in the year 1973 and moving ahead to be one of the leading Pharmaceuticals Company in India with presence in more than 50 Countries around the Globe and having an annual turnover of US$ 80 Million as of 2008.

A company with strengths in:
-- Manufacturing
-- Research & Development
-- Customer Relationship Management, Distribution & Logistics

Sr. Officer / Executive - Drug Regulatory Affairs
Experience: 2 - 4 Years
Location: Mumbai

Job Description
1. Compilation of dossiers.
2. Review and evaluation of DMFs.
3. Evaluation of technical documents from research centre and manufacturing location.
4. Knowledge pertaining to clinical and non-clinical data for dossiers compilation in CTD format.
5. EU CTD, Dossier Compilation, Dossier submission to regulated markets such as Turkey, Algeria, Morocco, Brazil.
6. Net surfing abilities for searching literature references.

Desired Candidate Profile
1. Should have relevant experience in the regulated markets.
2. Should have good communication skills (Oral & Written)
3. Should be computer savvy.

Address:
Ajanta Pharma
kandivali (W)
charkop
Mumbai,Maharashtra,INDIA 400 607

Email Address:
navreetk@ajantapharma.com
sachins@ajantapharma.com

http://www.ajantapharma.com

[Guest]

Sub :- Application for the suitable post in Regulatory, Corporate QA, Quality Assurance and any other suitable post.
Dear Sir / Madam
Being given to understand that there is a vacancy in your goodself concern. I hereby wish to apply for the above said post. In this connection my detailed Bio-Data is enclosed herewith.
I hope that my details shall furnish to your requirement and await for favourable reply as early as possible.
Bio-Data
S.A.RANGWALA
*Email : sab_251179 AT yahoo.co.in
Objective
Seeking a challenging and growth oriented Career in Industry where my current
experience & skill can be utilized in Conjunction with Company’s growth.
Relevant Background

Totally 10+ years experience in pharmaceutical with 5 years in International regulatory affair – in formulation for companies as follows :
M/s. SAMRUDH PHARMACEUTICALS PVT LTD. Goregoan (Mumbai).
WHO Approved (Sterile Liquid & dry Powder Injectables Both Parenteral & Veternary).
Export cum Regulatory Affairs Executive Feb 2009 till date.
- Gather all the various documentations and medical studies required by each country when registering the products.
- Checking of artwork & various other related technical documents.
- Ensuring the compliance of proper documentation, registration samples and pharmacopoeia standards to MOH authorities of Thailand, Ukraine, Russia, Philippines, and Vietnem as per ICH guidelines in ACTD/CTD format.
- Develop the Global Regulatory strategies.
- To coordinate with outsource agencies who will prepare dossiers in CTD Format as well as Technical Data and samples from third parties in CTD formats.
- To coordinate and work Zonal wise for CIS, Latin American, South American, South East Asian countries and African countries with Business Development Team.
- Participate in the development of new products and services
- Understand the requirements of each country when registering new products or new indications.
- Create a check list for all documents available and maintaining list, documents and records.
- Monitoring and Checking Of Registration And Re-Registration Dossiers Of Formulations Including Prescription Products, OTC Products, Semi- Regulated Countries And Non-Regulated Countries.
- Sorting Out Technical Queries Received From Agents And Health Authorities Of Respective Countries For Registration Of Products.
- Co-Ordination with Quality Assurance, Quality Control, R& D, Packing, Production for Technical Data.
- Collect data and prepare submissions to regulatory agencies
- Assist in developing procedures to ensure regulatory compliance
Oman Pharmaceutical Product Co. L.L.C ( with AL Bahja Group)
US FDA & TGA Approved (Solid dosage form Tablet & Capsules).
Officer Regulatory Affair May 2007 to Jan 2009.
- Basically involved in preparation, review and submission of dossiers as per
GCC guidelines.
Cipla Limited
Officer Regulatory affair Feb.2005 to April 2007.
- Basically involved in preparation, review and submission of dossiers for Asia
and Africa markets.
Jasmika Healthcare Pvt. Ltd.
Chemist in solid dosage form. Jan. 2001 to Feb.2005.
- Supervising, monitoring and solving discrepancies of the batch during production.
- Filling of the Batch records of the same.
Power Skills

I am articulate and well-trained. My background in science, along with my confidence in working with Asst. Manager, Manager and director of firm makes me an ideal candidate for pharmaceutical Regulatory affair. I am confident in my abilities.
Education

May 2000 Mumbai University
B.Sc. (Chemistry)-Royal college.
Ranchi University
“Appeared” for B.Pharmacy (Recognised by UGC).
Computer skills
- Have good knowledge of computer basics, windows operating systems, MS word, MS excel and MS PowerPoint.
- Operating ERP/SAP software.
Professional Achievements
Mar. 2004 Approved Technical person in “Tablet Manufacturing section” from FDA (Thane) Maharashtra.

[Guest]

CURRICULUM VITAE : ANJALI A. GAJBHIYE
SUB : LETTER OF INTRODUCTION AND CV
Dear Sir/ Madam,
I would like to take this opportunity to introduce myself to your organization and hopefully look forward to working with your esteemed company in the near future.
I have completed my Master of Pharmacy from Govt. College of Pharmacy, Amvarati University in 2008.
Presently working as Senior Q.A. executive in Agog Pharma LTD, vasai From May 2010 till date.
Also i worked as Q.A. officer in Pelltech Health Care PVT. LTD. Wada, Thane, From May 2008 to May 2010.
Also i worked as R & D officer in Pelltech Health Care PVT. LTD. WADA, From August 2008 to May 2009.
I am now seeking a challenging job, which will utilize my skills and provide opportunity for growth.
I will be grateful if you could interview me and assess my chances of working with your organization. For more information, I will be available at anjali.gajbhiye05 AT gmail.com or alternatively on my mobile no 09503742778
Thanking you and hoping to hear from you soon.


CURRICULUM VITAE
1.
ANJALI A. GAJBHIYE
E. Mail – anjali.gajbhiye05 AT gmail.com
CAREER OBJECTIVE :- To acquire skills and knowledge in the field of Pharmacy while aiming onwards higher growth and better prospects through dedicated efforts, competency, and hard work and to accept challenges in all fields with Positive view points.
WORK EXPERIENCE :-
- Working as Senior Q.A. executive in Agog Pharma LTD, vasai From May 2010 till date.
- Worked as Q.A. officer in Pelltech Health Care PVT. LTD. Wada, Thane, From May 2008 to May 2010.
- Worked as R & D officer in Pelltech Health Care PVT. LTD. WADA, From August 2008 to May 2009.
JOB PROFILE AS AGOG PHARMA :-
- Implementation of GMP guidelines.
- Preparation of quality manual & site master file.
- Preparation of validation protocol like cleaning, microbiological & analytical validation, Process Validation.
- Preparation, Revision & implication of Standard Operating procedure.
- Routin updation of documents.
- Maintenance of logbooks of various instruments.
- Reviewing of COA against specification.
- Conducting Internal audit/Self inspection of various department i.e. production, Q.C., stores.
- Coordinating with heads of various department for production activities.
- Coordinating with R&D and Regulatory department for registration purpose.
- Preparation of Master formula Record & master formula card.
- Market Complaint investigation, Vendor evaluation – R/M and P/M, Vendor audit- R/M
- Scrutinized the production documents.
- BMR, BPR, Change control, deviation, destruction, Method validation.
- Preparation of validation protocol and reports for new products and new location transfer product.
- Preparation, issuance and retrival of R/M,F/M,P/M Specifications and Standard Test Procedures.
- Updation of approved vendor list in co-ordination with supply chain and circulate to the concerned departments including the site of Manufacturing.
- Coordinating with Admistration and purchase department.
- Preparation and Maintenance of training records.
JOB PROFILE AS PELLTECH HEALTH CARE PVT. LTD. :-
AS QUALITY ASSURANCE OFFICER
- Maintenance of logbooks of various instruments.
- Perform IPQC in production
- Implementation of GMP guidelines.
- Preparation of validation protocol like cleaning validation.
- Maintain records of Self inspection
- Preparation of Process validation.
- Preparation of Analytical validation.
- Coordinating with Production, Stores, Quality control, R&D and Regulatory department for various QA documents.
- Arrange Vendor Audits for Raw Materials & Packing Materials as per schedule. Prepare reports & ensure compliance with Audit report.
- Updation of approved vendor list in co-ordination with supply chain and circulate to the concerned departments including the site of Manufacturing.
- Updation of approved vendor list.
AS R&D OFFICER
- Worked on Assay and Dissolution method validation on HPLC.
- Worked on Assay method Validation on UV.
- Worked on Assay and Related Substances method Development on HPLC.
- Formulation and Development of pellets and Trials.
- Drug Loding on Coating Pan, Fluid Bed Coater, Drug Core Pellets on Extruder
- Handling Capsule Hand Filling Machine
- Preparation of SAP, FPS, BMR Preparation, Blend Sheet Preparation,
- Stability study of finished product
- Routine analysis of finish product, raw material, newly developed product.
- Calibration of HPLC and UV spectrophotometer.
- Calibration of Dissolution Apparatus.
EDUCATION QUALIFICATION :-
M. Pharm (Pharmacognosy) : Govt. College Of Pharmacy, Amvarati University. (2008)
B. Pharm : K.B. C. P., Kamptee Nagpur University (2005)
INSTRUMENT HANDLING :
- HPLC - Shimadzu (Equipied with LC Solution software))
- HPLC - Waters (Equipied with Winchrom software)
- HPLC - Chemito (Equipied with Chemlab software))
- UV- spectrophotometer (Shimadzu)
- Dissolution Apparatus ( Electrolab, Lab India)
- Visible Melting Point Apparatus
- Disintegration Apparatus (Electrolab)
- Karl Fisher Apparatus
ACHIVEMENTS :-
- Qualified Graduate Aptitude Test in Engineering (GATE-2005)
PROFESSIONAL TRAININGS, PROJECTS :-
- Training in Universal Medicaments Pvt. Ltd., From 16. 05. 2005 to 26. 11. 2005.
COMPUTER SKILLS : -
- ERP, Pharma software, Microsoft office (MS- word, excel, power point), Internet.

[Guest]

Sub : Application for suitable post in regulatory affairs department.
Respected Sir/Madam,
I would like to apply for suitable position in Regulatory
My total experience is 1 year.
I would be working diligently and have much interest in knowing new aspects of research.
I kindly request you to consider me. Hope you may oblige.
RESUME
CARRIER OBJECTIVE :
- Seeking a challenging position in Regulatory Affairs where a diverse background & proven functional expertise will be utilized & enhanced..
- To excel in the field of Reguatory Affairs and give to best it.
- To prove myself best for the organization and to be an epitome of creativity teamwork and leadership.
SUMMARY :
- Post graduate from Shivaji university, Kolhapur with first class.
- One year experience in Cipla Ltd as a Quality control officer.
- P.G. Diploma in Regulatory Affairs.
NAME Rajashree Abhay Sagare (Karnale)

EMAIL-ID rkkarnale AT rediffmail.com
COMPUTER SKILLS :
- Well versed with computers
- Completed MS-CIT

EDUCATIONAL QUALIFICATION :
Degree College. University. Year. Percentage
P.G. Diploma in RA Global Institute of RA Chinchwad Pune 2010 64%

M.Sc.
( CHEMISTRY) Shivaji Uni. Shivaji Uni. 2007 69.00 %
Kolhapur Kolhapur.
B.SC.
(chemistry) Kisana Veer Shivaji Uni. 2005 80.40 %
Mahavidyalaya Kolhapur

H.S.C. Kisana Veer
Mahavidyalaya Kolhapur Board. 2002 59.17 %
PROFESSIONAL EXPERIENCE :
LABORATORY INSTRUMENT OPERATION :
- HPLC
- UV Spectrophotometer (Shimadzu & Unicam)
- Karl Fisher titrator (Veego & Metrohm)
- Dissolution Tester (Electro lab)
- Disintegration Tester (Electro lab)
- Autotitrator (Metrohm)Viscometer (Brookfield)
- pH meter
- Halogen moisture analyzer

PROJECT WORK :
Work on Sophisticated Analytical Instrument & Some Inorganic Test carried out in OKASA pharmaceuticals, Satara.
Course Content Of P.G.Diploma in RA
- The Aims & Structure of Regulation
- Regulatory Strategy
- Marketing Authorisation
- Non-Clinical Studies
- Cinical Trials
- Submission & Review
- Good Manufactuing Practice

[Guest]

CURRICULUM VITAE
DIPTI GUPTA
E-MAIL
dipti0810 AT yahoo.com
HOBBIES
- Reading books
- Singing
KEY SKILLS
- Excellent inter personal and project management skills
- Ability to manage multiple projects and priorities.
- Good understanding of various regulatory requirements.
- Ability to work effectively in a team environment while meeting deadlines for assigned projects.
- Hard working.
- Incredulous.
- Eager to learn.
- Responsible & Reliable
- Meticulous
“WELL VERSED IN COMPUTER SKILLS”
CARRIER OBJECTIVE
“To work in a stimulating environment where I can apply & enhance my knowledge, skill to serve the firm to the best of my efforts.”
AREA OF INTEREST
Regulatory Affairs Dept.
PROFESSIONAL EXPERIENCES
Company : Naprod Life Sciences Pvt. Ltd. Mumbai
Designation : Regulatory Officer
Duration : From October. 2009 to till date
Job Responsibilities :
- Review and Compilation of Registration Dossiers for Various Countries in (CTD , ACTD format) and as per countries guidelines .
- ASIA - Indonesia, Iran, Iraq, Lebanon, Malaysia, Myanmar, Nepal, Philippines, Sri-Lanka, Thailand, Vietnam, Bhutan.
- CIS - Belarus, Kazakhstan, Russia, Ukraine, Uzbekistan, Moldova.
- AFRICA - South Africa, Tanzania, Ethiopia, Ghana, Ivory Coast, Kenya, Madagascar, Morocco, Mauritania, Sudan, Togo, Uganda, Zambia.
- NORTH AMERICA /SOUTH AMERICA/ CENTRAL AMERICA -
Chile, Costa Rica, El Salvador, Guatemala, Nicaragua, Panama, Peru, Venezuela.
- LOCAL - Dr. Reddy’s Laboratories Ltd, Torrent Pharmaceuticals Limited, Lupin Pharmaceuticals Ltd.
- Co-ordinate with different departments to obtain essential scientific data and documents required for regulatory submissions.
- Checking and arranging Registration samples for various countries.
- Review of all quality documents.
- Preparation of FDA certification work.
- Maintain lists/documents/records.
- Handling Queries of Various Countries.
- Updation of Registration Dossiers.
KNOWLEDGE AREAS :
- Familiar with various Regulatory Guidelines (ICH, FDA, EMEA, TGA, CDSCO, etc.).
- Common technical Documents (CTD)-filing.
- Dossier preparation for various Dosage Forms.
- GMP regulations-India, WHO.
- Pharmaceutical process validation.
- Interfacing & strategic planning.
EDUCATION QUALIFICATIONS :
S.No Examination University Div.
1 M.Sc.- Biotechnology with ‘Pharmaceutical Biotech’ (2005-2007) HNBG Univ.
Dehradun (U.K.) I
2 B.Sc. (Microbiology)
(2002-2005) GGD Univ.Bilaspur (C.G.) I
3 H.S.C. (2002) S.K.P Singhania school (C.G.) I
4 S.S.C. (2000)
S.K.P Singhania school (C.G.) I

[Guest]

CURRICULUM VITAE
Name : USHA RAMCHANDRA CHATAULE
E mail ID : geeta_2_rose AT yahoo.co.in
Educational Qualification :
Educational Qualification School/ college Percentage
B. Pharmacy (2006) S.N.D.T (C.U.Shah college of pharmacy) 62.32 %
H.S.C (2002) S.N.D.T (S.V.T College Juhu Campus) 60.15 %
S.S.C (2000) Dureulo Convent High School 65.75%
Additional Professional Qualification
Post Graduate Diploma in Clinico-Regulatory & Patents (PGDCRP) from Centre for Advancement in Health Sciences, Ruia College. (May 2007 to November 2007)
Objective : To be able to grow with the organization & with the new requirements of Registration Process.
Extra Activities : Industrial Training at P.P.I.L Navi Mumbai.
Seminar on Anti Obesity Drug Sibutramine.
Computers : Windows 2000/XP, Microsoft Office Suite (Word, Excel,
PowerPoint) & Internet.
Hobbies : Listening Music, Cooking & Gardening.
- Work Experience
As production coordinator for 4 months in T&T Pharma Care at Thane.
Duration : From May 2006 to August 2006
- Job Responsibilities
- Checking Raw material & Packing material.
- Securitinizations of finished goods & Production dept work.
- Performing In Process Quality Control Checks for Tablets, Capsules & Dry Syrup.

- Work Experience
In Quality Assurance Departments as a Q.A Chemist. In Bombay Drug House, Akurli road, Kandivli (E) Mumbai 400101.
Durations : From September 2006 to January 2007.
- Job Responsibilities
- Preparation of documents as per required by the WHO-GMP such as Standard Operating & up dating of Specification of Raw materials, Bulk & Finished Product for various dosage products.
- Monitoring Stability Studies Data & Performing IPQA Checks & giving line clearance.
- Checking Log Books for Tablets, Capsules, External Liquid, Raw material, Ointments & Injection Departments.
- Work Experience
In Regulatory Affairs as Regulatory officer in M/s Aurochem Laboratories (I) PVT.LTD. Kandavli (E) Mumbai- 00101.
Duration : From January’ 2007 to May’2010. (worked in Factory for 3 months)
- Job Responsibilities
- Administrative work :
- Preparation of Product Approvals & Free Sale Certificate, Certificate of Pharmaceutical product
& renewal of documents & WHO GMP.
- Authentication of documents by respective Embassies & Consulates.
- Dossiers
- Handling of dossiers for Non Regulated, Semi-Regulated, CIS markets. Countries like Latin American, Central American, South African, Asian countries. Also hand on CTD dossiers for Ukraine.
- Preparing dossiers for Tablets, Capsules, liquids & dry powders and Ointments & Creams.
- Co-ordinate with various departments at manufacturing sites and within the organization regarding Technical data, sample preparation & shipments.
- Solving the queries related to dossiers.
- Preparation of registration status of each country.
- Artwork Dept
- Preparation of text matter for packing materials like carton, labels, foils & checking.
- Preparation of pack inserts, checking & giving approval for the artwork & design of
Carton, labels, foils & Leaflets.
- Co-ordinate with graphic artists for preparation of artwork.
- Work Experience
As “Sr. Executive in Regulatory Affairs” In Shree Ganesh Pharmaceuticals at Matunga East near Maheshwari Udayan.
Duration : From May’2010 to January 2011.
- Job Responsibilities
- Administrative work
- Preparing the FSC & COPP for Thane & Pune & Gujarat FDA.
- Translation of documents in Spanish from respective Institution & Legalisations of documents from respective Embassies & from BCCI.
- Dossiers
- Preparing the dossiers for Injections, Tablets & Capsules for Latin American & South African countries in ACTD & as per guidelines. For Countries like Costa Rica, Panama, Thailand, Cuba etc.
- Preparing the dossiers for Anti Cancer drugs, Anti-tuberculosis drugs, Antibacterial drugs i.e Sterile powders, Hormones etc.
- Checking the Art Work & revising as per parties requirements.
- Handling quires & reply to mail’s of parties.
- Other Activities
- Preparing documents for courier.
- Checking the dossiers of subordinates & Guiding the Trainees & Officers.
- Updating the registration status of dossiers.
- Attending meetings with Directors & intra departments.
- Preparing the Presentation, Inductions on power point.
- Work Experience
Currently working as Regulatory Officer at NEON LABORATORIES LTD. At Andheri East.
Working as Team leader.
Duration : From March 2011.
- Job Responsibilities
- Working on South African countries like Uganda, Tanzania, Sudan, Nepal, Bhutan, Kenya etc.
- Checking of dossiers of subordinates & training the subordinates
- Query reply & correspondence with the Export dept, Factory, Fdd, Product development etc for the requirements.
- Preparation & checking of COPP, FSC, Product Permission, Test license & online registration of FSC & FDA Approval.
- Preparing the status of countries & reports to the directors.
- Art work checking for self & Loan License & Std Pack insert for products.
- Checking & preparation of List of MFR, PRC, Master formula & Manufacturing Process, TCF form, art work.
- Strength
- Simplicity in life.
- Thinking positively.
- Determined.
- Helping Subordinates.
All details given above are best of my knowledge.
Place : Mumbai
Date :
(Usha Ramchandra Chataule)

[Guest]

CURRICULUM VITAE
PUSHPLATA CHOUGULE
E-Mail : pushuchougule AT yahoo.com

CAREER OBJECTIVE :
To obtain a challenging position that will enable me to use my strong organizing skills, educational background, and ability to work with people in health care profession.

ACADEMICS :
Examination Year of Passing Percentage Class Obtained University/Board:
M. Pharmacy 2012 60 I Class University of Mumbai
B. Pharmacy 2010 61.41 I Class University of Mumbai
H.S.C 2005 54.50 II Class Maharashtra State Board
S.S.C 2003 77.47 I Class with distinction Maharashtra State Board

RESEARCH PROJECT :
- Completed research project funded by university of Mumbai, of second year M. Pharmacy entitled “Pharmacological Evaluation of Herbal Extract For Antioxidant Property”

PROJECT DETAILS :
- Project Topic : Pharmacological Evaluation of Herbal Extract for Antioxidant Property.
The Entire Project covers all the stages right from the procurement of the herbal and then its subsequent extraction with a suitable solvent and then carrying out its phytochemical screening followed by In- Vitro studies as well as In-Vivo animal studies and correlation of the data obtained from the studies to prove the thesis.

TECHNICAL SKILLS :
- Handling different analytical and laboratory tools like UV- Vis Spectrophotometer, HPTLC,FTIR, Column Chromatography.
- Measurement of rat ECG using BIOPAC instrument.

LABORATORY SKILLS :
- Conversant with different animal models for studying different conditions like myocardial infarction,
- testicular toxicity, gastric ulceration, diabetes, inflammation, analgesic,Hepatoprotective.
- Conversant with handling of experimental animal like rats, mice.
- Different routes of administration like oral, intra-peritoneal, subcutaneous.
- ECG recording of rats.

RESEARCH PUBLICATIONS :
- Silymarin- A review on Pharmacodynamics and Pharmacological Approaches in Journal of Applied Pharmaceutical Sciences
- In vitro Antioxidant Activity of Ethanolic Extract of Centaurea behen in Journal of Applied Pharmaceutical Sciences

SEMINAR AND PRESENTATIONS :
- Acceptance of Paper for Poster Presentation in 63rd Indian Pharmaceutical Congress.
- Presented Seminar on Migraine in the year 2008.
- Presented Seminar on DNA Vaccines in the year 2011.
- Participated in BVSEMICON-2010 as Student delegate in Bharati Vidyapeeth’s College of Pharmacy.
- Participated in Increased Drug Failure in Market :Safety Questionable 2011 as Student Delegate in Bharati Vidyapeeth’s College of Pharmacy
- Participated in Applied and Pure Association of Pharmacology as Student delegate in Institute of Chemical Technology.

SUMMER TRAINING :
- 2009-One Month Training in Gopaldas Visram Limited, Mahape, Navi Mumbai in Quality Control, and Quality Assurance of Tablets, Capsules, Ointments, and Liquid orals.

CO-CURRICULAR ACTIVITY :
- Participated in group dance in ‘Spandan’ annual festival of Bharati Vidyapeeth’s College of pharmacy in year 2011 and 2010
- Participated in group dance in Rx festival in year 2007 & 2008

COMPUTER SKILLS :
- Completed the Basic Course in ‘MS OFFICE’ with ‘Excellent’ Grade

[Guest]

Mr. TODKAR AMOL RAMAPPA
Email-amolrtodkar AT gmail.com

CAREER OBJECTIVE:
To form a strong foundation of knowledge as a prerequisite for research, administration and management to become a learned professional who is at forefront to deal with the upcoming challenges.

AREA OF INTEREST:
1. Production department
2. Research and Development
3. Intellectual Property Rights (IPR)
4. Drug Regulatory Affairs (DRA)
5. Quality assurance and Quality control.

EDUCATIONALQUALIFICATION :
Examination University/Board Year of Passing Percentage Class:
M.Pharm I year Amravati Feb 2010 56.70% second class
B.Pharm. Amravati April 2010 58.58% Second class
D.Pharm. MSBAT June 2006 79.80% First class
H.S.C Aurangabad Feb 2004 65.00% First class

S.S.C Aurangabad March 2002 78.80% First class
CAREER ASPIRATION:
I am doing M.Pharm in Pharmacology still I am having interest to work in Production Department. I am having knowledge related to Pharma subjects such as Advanced Pharmaceutics and Pharmacology because I have studied both as Elective subject in first year M Pharm.

RESEARCH PROFILE :
A study on wound healing activity of ficus benghalensis gel.
Guide Name : Prof. U.m.Joshi.

PERSONAL DETAILS :
Name : Mr.Todkar Amol Ramappa
Date of Birth : 18th Feb 1986
Marital Status : Single
Languages Known: English, Hindi, and Marathi
Sex : Male
Nationality : Indian

SCIENTIFIC EXPERTISE :
Instrument used - Experience in handling of different instruments such as compression machine 10 station, Erweka & Monsanto Hardness Tester, Friabilator, Disintegration Test Apparatus, Dissolution Test Apparatus UV-Visible spectrophotometer, Microwave ove, Rotary evaporator.
Computer Proficiency - Windows operating systems and application software : MS Office, Chem Draw and Corel Draw. Scientific data retrieval from Internet portals including Science direct, Pub med etc.
PUBLICATIONS .
Conference Attended :
1. Three day National conference and paper presented on Development, regulatory and Intellectual aspect of drug delivery systems held at amrutvahni college of pharmacy, sangamner at feb- 2012.

DECLARATION :
I hereby declare that all the statements made in this resume are true and complete to the best of my knowledge and belief.
Date : - 15 /6 /2012
Place : -selu Mr.TODKAR AMOL RAMAPPA

[Guest]

RESUME
VIJAY BADGUJAR
E-mail : vijaypr2 AT yahoo.co.in

Experience : Presently working in Macleods Pharma Ltd. Located at Daman . Quality Assurance Department ‘ As a Assistance Manager since Jul. 2010.

Qualification : D.Pharmcy from Maharashtra & M.Sc. Chemistry ,from Madurai Kamraj University.

Computer Skill : MS- word , MS-Excel , MS-Power Point & ERP based on Oracle , SAP module, Caliber LIMS.

Strengths : Maintaining good interpersonal relationships , Active involvement in any sort group , Motivating and Directing them.

Achievements : * Suggestion Award
* Active member in the validation team of Process Validation and Equipment Qualification. Analytical method validation ,
* Prepared various document as per MHRA for Solid Oral .
* Knowledge of Microbial limit test for solid dosage.

Trainings Attended : * Communication skill
* Team Building
* 21-CFR
* Cleaning validation

JOB RESPONSIBILITIES :
In Wockhardt Ltd., Daman ,in Quality Assurance Dept as Sr.chemist , from Aug,1996 to May’2007
a) Creation, implementation and maintenance of Standard operating procedures.
b) Daily quality assurance functioning Batch Records review and finished product release for sale
c) Daily issued BMR , BPR , SOP’s
d) Handling of Deviations , Change controls , product quality issues.
e) New facility of Tablets for Environment , Manufacturing process , Validation of water system
f) Document control training programme.
g) Prepared Annual product review.
h) Instrument and Equipment qualification
i) Handled Sophisticated Instruments like
- HPLC with Autosampler ,
- FTIR,
- UV-vis spectrophotometer.
- Auto titrator for water and karl-fischer titrations ,
- Brookefield viscometer.
j) Analysis of Raw material , Finished product and Packing material.
k) Preparation and Implementation of Manufacturing process validation with protocol.
l) Stability study monitoring.
m) Trend analysis
n) Prepared Holding time study blend protocol.
o) Review Report RM / FP / PM
p) Testing of Microbial limit test for solid dosage.

Ajanta Pharma Ltd. , Paithan , Aurangabad
Executive Quality Control Stability Section and Packaging section. June’ 2007 to May 2008.
a) Stability study sample received.
b) Stability sample protocol preparation.
c) Stability sample charging and withdrawal.
d) Equipment qualification IQ/ OQ /PQ
e) Stability chamber humidity and temp.record maintain.
f) Preparation of Stability Trend analysis.
g) Prepared Monthly stability schedule.
h) Prepared Stability analysis specification.
i) Prepared documents as per DRA requirement.
j) Review Report
k) Major role in new LIMS- caliber software specification filled.
l) Monitoring, Analysis Planning and Review PM Report

M.J. BioPharma Pvt Ltd. , Taloja, Navi Mumbai.
Executive Quality Assurance. May 2008 to March 2009.
a) Equipment qualification IQ/ OQ /PQ
b) SOP Preparation.
c) BMR & BPR Preparation.
d) Preparation and Implementation of manufacturing process validation with protocol.
e) Daily issued BMR , BPR , SOP’s
f) Handling of Deviations , Change controls
g) Prepared Annual product review.
h) Daily work allocation to staff.
i) Handling of IPQA related Issue.
j) Review BMR , BPR .

Aglowmed Ltd. , Daman, (U.T. ).
Executive Quality Assurance. March 2009 to Jul.2010.
a) Equipment qualification IQ/ OQ /PQ
b) SOP Preparation.
c) Review, Updation and Preparation of BMR / BPR .
d) Preparation and Implementation of manufacturing process validation with protocol.
e) Daily issued BMR , BPR , SOP’s
f) Handling of Deviations , Change controls
g) Prepared Annual product review.
h) Daily work allocation to staff.
i) Handling of IPQA related Issue.
j) Review, Updation and Preparation of SMF / VMP.
k) Internal audit as per annual schedule.
l) Vendor audit RM , PM & Out side Laboratories.
m) Preparation of Training schedule, matrix, on the job training to sub-ordinates, Executive summary and Monthly summary Report.
n) Preparation and Updation of vendor List and maintaining Vendor Qualification audit reports. at plant level by coordinating with Corporate Office.
o) Local FDA Licensing Application.

Macleods Pharma Ltd. , Daman, (U.T. ).
Assistance Manager IPQA & Validation ’ July 2010 to Till date.
a ) Review, Updation of Master BMR / BPR .
b) Handling of IPQA Activity & Issues.
c) Handling of Non-conformance.
d) Handling of Change control , Deviation related IPQA
e) Handling of Process Validation
f) Handling of ANDA Validation.
g) Internal audit as per annual schedule.
h) Regular BMR & BPR Reviewed.
i ) Finished product released in ERP system.

GMP Inspections : : Actively involved in preparation of following Audits.
US FDA
- MHRA-UK
- WHO-GENEVA
- INVISA
- WHO
TANZANIA
UGANDA
UKRAINE
(V.L.Badgujar.)

[Unregistered]

LALITA PARDHI
lalita_pardhi AT rediffmail.com

CAREER OBJECTIVE :
Seeking to work in an organization where my knowledge and professional skills can be shared and enriched in conjunction with the organizational goals. To continuously initiate positive endeavors towards achieving value addition as a team member in an organization that appreciates and recognizes quality performance.

EXPERIENCE :
1 :DANA PHARMACETICAL PVT. LTD. . AMBERNATH (MUMBAI) as a
“QA OFFICER” From MARCH 2013 TO TILL DATE.

2 :DANA PHARMACETICAL PVT. LTD. . AMBERNATH (MUMBAI) as a
“QC OFFICER” From MARCH 2012 TO MAR2013.

EDUCATION QUALIFICATION :
DEGREE YEAR INSTITUTE PERFORMANCE
M-pharmacy 2012 RGPV-BHOPAL Passed with 1st Division
B-pharmacy 2010 RGPV-BHOPAL Passed with 1st Division (68%)
H.S.C 2003 M.P Board – Bhopal Passed with 1st Division(71%)
S.S.C 2001 M.P Board – Bhopal Passed with 1st Division (81%)

SEMINAR / PROJECT :
PROJECT : M-pharmacy
MAJOR PROJECTSimultaneous Estimation of Atenolol & Indapamide in combined tablet dosages form using RP HPLC.(Dissertation Part II)
MINOR PROJECTSimultaneous Estimation of Atenolol & Indapamide in combined tablet dosages form using RP HPLC.(Dissertation Part I)
PROJECT : B-pharmacy
MAJOR PROJECTOn Organic aromatherapy products for energy and healthcare.
MINOR PROJECT. Visited to Glanmark Industries in Goa & report submission.

SEMINAR :
Seminar on tablet coating.
Seminar on Handling of U.V.

JOB PROFILE :
2 :DANA PHARMACETICAL PVT. LTD. . AMBERNATH (MUMBAI) as a
“QA OFFICER”In Tablet and capsule From MARCH 2013 TO TILL DATE

JOB RESPOSIBILITY :
1. To distribute SOP ,Formats .Specification, TDS.
2. To check and record temperature and humidity of all department.
3. To give line clearance in production and (tablet and capsule),store and packing department.
4. To carry out in-process check.
5. To issue and retrieve BMR and BPR as per production requisition slips.
6. To check and maintain approved art work.
7. To review BMR and BPR.
8. To load stability samples and prepare stability calendar.
9. To prepare COA and MCOP and trend data analysis.
10. To Monitor QCS inspection and check packing list for local and export.
11. To maintain all logbooks and report on line.
12. To prepare schedule for worker and staff training.

1 :DANA PHARMACETICAL PVT. LTD. . AMBERNATH (MUMBAI) as a
“QC OFFICER”In Tablet and capsule From MARCH 2012 TO MARCH 2013
1. To prepare reagents and proper labelling of all reagents.
2. To follow the standard operating procedure for QC department.
3. To carry out daily verification of balance as per SOP and maintaining the record.
4. To carry out water analysis.
5. To maintain temperature humidity and cleaning record.
6. To carry out analysis of RM/PM allotted by the supervisor.
7. To carry out sampling of RM/PM as pre MRN.
8. To prepare and standardized volumetric solution,buffer solution etc.
9. To receive and verify the chemical and reagent as per the SOP and keeping the respective record of the same.
10. To maintain control sample of active raw material.
11. To maintain all logbooks and report on line.

HANDLING OF MACHINE :
1. Handling of UV.
2. Operate karl fisher titration.
3. Handling of Dissolution test apparatus.
4. Operate Disintegrations test apparatus.
5. Operate Friability test apparatus.
6. Operate Hardness test apparatus.
7. PH meter handling.
8 .Handling of FTIR

Audit Faced :
FDA
Nigeria Audit
WHO

PERSONAL DETAIL :
NAME : Lalita pardhi
Mr. M. R. Pardhi
FATHER’S NAME :
SEX :
MARITTAL STATUS : Unmarried
DATE OF BIRTH : 12-June-1985

I certify that the information I have given in this resume is true to my knowledge and belief.

Place : Ambernath (Lalita pardhi)

[Unregistered]

Shital Prajapati
Email id : shitalprajapati47 AT gmail.com
rohitvp4u AT gmail.com

CAREER OBJECTIVES :
I want to use my potentials in the best possible way, so as to lead to my growth as an individual and to be successful in my career.
Simultaneously would like to work in synergy with the industry/organization, contributing in its growth and development which in turn would make me a worthy employee and a formidable team player.

ACADEMICS :
School / College Board /University Year Of Passing Grade
M.PHARM (PMRA) K.J. Institute Of Pharmaceutical Education & Research,Vadasma, Mehsana Gujarat Technological University 2nd Semister continue Result awaited
M.PHARM (PMRA) K.J. Institute Of Pharmaceutical Education & Research,Vadasma, Mehsana Gujarat Technological University 1st Semister 7.60 SPI
B-Pharm L.B.Rao Institute Of Pharmaceutical Education & Research, Khambhat B-Pharm April-2009 1st
H.S.C New English School, Nadiad H.S.C March-2005 1st
S.S.C ST. Mary’s High School, Nadiad S.S.C March-2003 1st

JOB PROFILE :
Name of Organization : Cadila Healthcare Limited,
Location : Sarkhej-Bawla, N.H. No.8A, Moraiya, Taluka-Sanand,
Ahmedabad, Gujarat.
Date of joining : 8th September 2009 to till date
Position : Scientific officer –International Regulatory Affairs Department
Market : Russia, Ukraine, Mexico


JOB RESPONSIBILITIES :
Preparation and submission of dossiers for Europe, Mexico , Russia and Ukraine market as per country specific guidelines.
Proper and in time response of Queries and other regulatory requirements by Regulatory Authority.
Review of Specification and Certificate of analysis for finished product, Excipients, API, Working Standard and Packaging Materials, Stability data, Stability Protocols.
Process validation Protocol, Process validation Reports, Analytical documents and Innovator’s Certificate of analysis other technical documents required for compilation of dossiers.
Review of change control for Specification and various stage chromatograms and calculation sheets for verification of results for various test methods for Stability data, Analytical validation reports, Certificate of analysis and Specification for Finished Product, Excipients, Working Standard and API.
Review of executed Batch Manufacturing and Packaging Records of Exhibit Batches.
Review and Legalization of documents like COPP, GMP Certificate and Mfg. License.
Archival of Submitted dossiers.
Ability to prepare dossiers as per CTD guidelines.
Correct understanding of regulatory guidelines [ICH, CTD] for registration of dossiers for various Drug Products.

Tracking the exhibit batch progress :
Execution, stability login, stability complete and then filing.
Review and approval of analytical and manufacturing documents.
Co-Ordination, Review and follow up to obtain API Related information.
Co-Ordination and follow up of various departments for collection of documents for in time response of Queries, other regulatory requirements and submission of dossier.
Timely Preparation and Submission of annual Report to Agency.
To ensure the status file is current always and must be available as and when required to the Management.

ACHIEVEMENTS :
I was awarded in the Quarterly Reward & Recognition Programme for significant contribution during Q-3 (FY-2011) which led to the timely and successful product development for Mexico Market.

PERSONAL PROFILE :
EMOLUMENT :
CTC : 2.13 Lacs / annum
Exp : As per company Norms
Contact Time : After 5.30 p.m as 9 a.m to 5.30 p.m is office time
Preferable location : Mumbai area [Western line]

[Unregistered]

Rinki Gangar
E-Mail : rinkiugangar AT gmail.com; rinkigangar.888 AT gmail.com

ACADEMIC CREDENTIALS :
** Advanced Post Graduate Diploma in Drug Regulatory Affairs and Intellectual Property Rights (DRIP) from SBM, NMIMS University, Mumbai in 2012.
** B.Pharma from SPTM, NMIMS University, Mumbai in 2011.
** D.Pharma from MET, MSBTE, Mumbai in 2008.

PROFESSIONAL EXPERINCE :
SAMRIN SERVICES PVT. LTD. SEP’2012- PRESENTLY
Executive – Regulatory Affairs
** Preparation and compilation of dossier for Angola
** Drafting dossier for OTC- ointment, creams, oral liquids, eye drops & aerosol sprays (Pharmaceutical, cosmetics & Ayurvedic)
** Filling Registration Form of suppliers with MOH
** Preparation of technical documents like COA
** Co-ordination with suppliers for data required for preparation of dossier and follow up for technical documents required for registration.

VEDIC LIFESCIENCES / CLINACE JULY’ 2012-August’ 2012 Trainee Clinical Data Manager
Handling clinical data study of Diabetes, Insomnia and Chronic Rhinitis
** Data Entry & Data Validation using Epi-info software
** Co-ordinate with CRA for discrepancy
** Validation of data and updating database

SKILLS & COMPETENCY :
** Regulatory Affairs
- Dossier drafting filling
- Regulatory Submission
- Regulatory Requirements
** Intellectual Property Rights
- Patents , Trade Mark & Copy Right Law

ACADEMIC PROJECT WORK :
** Community Pharmacy “Patient Education Leaflet.”
** Pharmaceutical management “Brand Positioning Strategies in Pharmaceutical Industry.”

INTERNSHIPS :
** Interned as trainee in Stability (quality assurance and quality control) department at Palghar plant of Macleod’s Pharmaceutical’s, for 3 months ending May 2012.
** Practised as Dispensing Pharmacist at Rushabh Medical, for 3 months ending August 2008.

EXTRA CURRICULUM :
** Won 1st prize in University of Pune sponsored poster presentation competition in February 2012.
- Topic : “The Impact of EU- INDO FTA on the Indian Pharmaceutical Industry on a Global Front”
** Attended Seminar on ’Herbal Product : Regulatory Aspects’ organized in June 2012.
** Have basic Knowledge in Activities related to Imports and Export.