www.hemmopharma.com Hemmo Pharmaceuticals Pvt Ltd Mumbai : Pharma Regulatory Affairs Officer

[mskavi]

HEMMO PHARMA Pvt Ltd Mumbai, Mumbai Suburbs : Regulatory Affairs Officer

Designation: Regulatory Affairs Officer
Experience: 2 - 6 Years
Location: Mumbai, Mumbai Suburbs

Job Description:
Selected candidate will be responsible for Preparation of DMF for US, Europe, Canada and other markets and response to different queries from regulatory agencies like USFDA and other. Preparation and maintenance of regulatory submissions and technical files.

Desired Candidate Profile:
Candidate should be B.Pharma/M.Pharma/Msc with 5 years experience in Preparation and maintenance of regulatory submissions and technical files (atleast 2 years in Pharmaceutical Dossiers writing/ regulatory affairs)

Company Profile:
A reputed peptide bulk drug manufacturer and worlds leader in manufacturing and supply of Oxytocin . Has US FDA approvable plant at Navi Mumbai.

Address:
HEMMO PHARMA
C-43 T.T.C. Industrial Estate, Thane Belapur Road,
Tubhe
Mumbai,MAHARASHTRA,INDIA 400613

To apply, send CV to Email Address: jobs@hemmopharma.com
Website: http://www.hemmopharma.com

Keywords: Regulatory officer , Pharma , USFDA , DMF

[Guest]

Hello
Sir/ Madam
I am P.somasekhara babu, I have completed M.pharmacy (Pharmacognosy),from HKE’S College of pharmacy, Rajiv Gandhi University Of Health Sciences, in the academic year (2009-2011), forwarding my resume. Please kindly respond to it. I will do work with my full effort.
Thanking you
P.somasekharbabu
Email : somasekhar123babu AT gmail.com

To apply my knowledge and skills to explore new facets of research and achieve excellence and innovate in the field of Pharmacognosy & Phytochemistry.

Qualification Board / University Year of passing % :
M.Pharm (Pharmacognosy) HKES’s college of pharmacy Gulbarga 2011 69%
B. Pharm Siddhartha college of Pharmaceutical sciences, Vijayawada 2008 69 %
Higher Secondary Vignana bharathi junior college, Chirala 2004 74 %
S.S.C. Z.P.H.School, Panguluru 2002 78 %

Work experience :
8 moths teaching experience in Malineni Lakshmiah College of pharmacy, singarayakonda, prakasam District.

- In M.Pharm project was carried out “Preliminary phytochemical screening and study of hepatoprotective activity on fruits of Luffa acutangula var amara’’ F :Cucurbitaceae at H.K.E.S’s college of pharmacy, Gulbarga.
- In B.Pharm project carried out “New RP-HPLC method for the estimation of drotavarine hydrochloride” at SCOPS, Vijayawada.

Regulatory Affairs, Quality Assurance, Production, R & D,
- In vivo screening of Hepatoprotective Activity
- Handling of HPLC
- Well versed with computer softwares like, Chem draw, Graphpad Instant etc.,
- Presentation on “The revolution of stem cell therapy in the current medicine”, in Adisankara College of pharmacy, Guduru.
- Attended the conference in 61st Indian Pharmaceutical Congress.
- Attended the CME on metabolic disorders, resent trends in clinical biochemistry, in M.R Medical College, Gulbarga.
- Attended the ICMR sponsored two days national ADD & DDPD, organized by BLDEA’S college of pharmacy, Bijapur.
- Presentation on “New RP-HPLC method for the estimation of drotavarine hydrochloride” during 15th Annual national convocation of APTI-2010, Shilpakala vedika, Hyderabad.
- Dr. Jaganath rao’s Success Secrete certificate was awarded in Personality Development Work Shop at H.K.E.S’s college of pharmacy, Gulbarga.
- Completed (B.Pharm) 1 month Industrial Training in Inventies drug delivery systems, Hyderabad, Andhra Pradesh,India.
- Born on 7th April 1987, single, Indian.

- Languages Known : English, Hindi and Telugu.
- Hobbies : Travelling, cooking.

[Guest]

CURRICULUM VITAE
Miss Rosalee Ramesh Jain
Email : rosemerry.jain AT gmail.com

OBJECTIVE :
To be associated with a progressive organization which can provide me with a dynamic work sphere to extract my inherent skills as a Professional, use and develop my aptitude to further the organization’s objectives and also attain my career targets in the progress.

EDUCATIONAL PROFILE :
EXAMINATION YEAR OF PASSING UNIVERSITY/ BOARD PERCENTAGE :
FINAL YEAR
SEM 8 MAY 2010 MUMBAI 70.66%
SEM 7 NOV 2009 MUMBAI 63.67%
TY B.PHARMACYSEM 6May 2009 MUMBAI 66.18%
SEM 5 NOV 2008 MUMBAI 78.83%
SY B. Pharmacy
SEM 4 MAY 2008 MUMBAI 64.83%
SEM 3 NOV 2007 MUMBAI 64.77%
FY B. Pharmacy
SEM 2 April 2007 MUMBAI 62.15%
SEM 1 NOV 2006 MUMBAI 65.50%
MHT CET MAY 2006 DMER 122/200
H.S.C. Feb 2006 MAHARASHTRA 64.17%
S.S.C. Mar 2004 MAHARASHTRA 82.66%

Current Profile :
Currently working as Regulatory officer in NV Remedies. Pvt. Ltd.
Job description :
1. Compilation of Dossiers of CIS countries in CTD format.
2. Coordination with plant to obtain necessary support for dossier compilation.
3. Maintaining records of all incoming and outgoing documents.

Work of Experience :
8 months of experience in NV Remedies. Pvt. Ltd

Academic Project :
Project report and presentation on subject “LIPOSOMES AND NEOSOMES”.

INDUSTRIAL TRAINING :
One month training in PHARMAX Pharmaceutical industry
During the period 1-6-09 to 30-6-09.

COMPUTER SKILLS :
Familiar with Microsoft word, Powerpoint, Excel and Photoshop CS3

AREA OF INTEREST :
Regulatory Affairs

EXTRA CURRICULAR ACTIVITIES :
First prize winner in 100 meter running race in the year 2010
First position in Cricket in the year 2010
First prize winner in Group Dance in the year 2009
First prize winner in Flower Arrangement in the year 2009

[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.

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.

WORK EXPERIENCE :
- Mar 2010 - Till date, Unibios Labratories Ltd., Saki Vihar Road as Officer in Pharma Regulatory Affairs department.
- 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

[Unregistered]

Sub :- Application for the suitable post in QC/QA/ADL/RA.
Respected Sir/Madam,
I the undersigned Swati G.Kale is interested in your esteemed organization to seek opportunity for the suitable post.
I have 8.5 years experience in pharma QC.
I am working as Jr.Exe. in MEYER ORGANICS THANE.I am looking forward to use my expertise and knowledge in your esteemed organization under your kind guidance.

Hope to hear favorable reply from you,
Thanking you in anticipation,
Yours Sincerely,
Swati G.Kale

RESUME :
SWATI GANESH KALE
Email. swati_auti AT rediffmail.com

Career Goal :
Seeking a good position in organization and contributing to its success at the same time constantly upgrading my skills and potentials

Academic Qualification Profile :
Qualification Institution Year of Passing Grade/class :
Post Graduate Diploma Mumbai University 2005 Second class
BSC (Applied Chemistry) Mumbai University 2004 Second class
HSC Mumbai University 2001 Second class
SSC Mumbai University 1999 First class

Experience : Total 8.5 years of experience in the Quality Control
Company : MEYER ORGANICS PVT.LTD.(THANE)
Period : March 2007– till date (6 Yrs)
Designation : Jr. Executive
Job Profile :
** STABILITY : (Sept.2012 to till Dt)
** INHS Calibration of Stability chamber .
** Maintenance & cleaning record of Stability chamber.
** SOP & format preparation for chamber.
** Invoice preparation.
** Shedule list preparation,
** Export COA Preparation
** MIS REPORT
** DOCUMETATION & ANALYSIS of R&D : (Aug 2010 to Aug 2012)
** Pilot batches of R&D , Stability of R&D.
** COA preparation, Invoice preparation.
** Fulfill the REGISTRATION requirement :
** Provide the MOA, FPS, Method validation.
** INHS : PROCESS VALIDATION (June 2008 to July 2010)
** METHOD VALIDATION Requirement of registration as per the Country.
** Vendor Development : (March 2007 to MAY 2008)
** During the vendor development , Joined analysis with vendor.
** Sampling : Raw Materials, Finished Product , In Process.
** Control sample entry. ERP operation, R. M entry, F. P entry.
** Maintain the stock for glassware’s and calibrate accordingly.
** Export COA Preparation
Instrument handled :
** Dissolution of Tablets instrument. (Make : Electrolab)
** Karl Fisher. (Make : Spectralab)
** Ultra Violet. (Make : Analytikjena, Shimadzu)
** pH metery. (Make : Lab India)
** HPLC (Make : Agilent 1100 Series)
** AAS (Make : Perkin Elemer)
** FTIR spectrometer (Make : Shimadzu – 1800)
Job Responsibility :
** Stability of FP for regular batches & prepare the sheet to maintain the documents,
** Analysis of pilot batches of R&D ,Registration batches & provide the MOA,FPS,COAS.
** Solve the problems of R&D, Stability regarding to analysis.
** Communicate with R&D, QA to intimate the status.
Periodic meeting with R&D & Stability regarding : New formulation, Reports, Methods. to minimize the analytical quarries.
** Documentation : Revised the SOP , Format of stability chamber.
** Maintain the cleaning record, temp humidity record of all area & stability chamber.
** Monthly Invoice preparation, MIS Report, schedule list of samples.
** Daily Work Allocation to our subordinates.
** To train & guide to subordinates.
** Verified the Methods of development samples.
** Prepare the COA’s for product registeration, checking of MOA's ,FPS .

Company : KILITCH DRUGS INDIA LTD. (PAVANE)
Period : June 2006 – March 2007 (9 months)
Designation : Chemist
Job Profile :
** Analysis of Inject able : Finished Products and Raw Materials, Stability study, In Process Quality control checking
** Preparation of Data for Process validation and documented the data as per the party required
** Calibration of HPLC and GC
Instrument handled :
** High Performance Liquid Chromatography.
** Gas Chromatography

Company GLAXO SMITH KLINE (THANE)
Period : October 2004 – April 2006 (1.6 yrs)
Designation : Trainee Chemist
Job Profile :
** Sampling & Analysis of steroid, Intermediates,
** Finished Products and Raw materials,
** Water analysis
Instrument handled :
** High Performance Liquid Chromatography.
** Gas Chromatography.
** Thin Layer Chromatography.
** pH metery.
** Infra red spectroscopy.
** Atomic Absorption spectroscopy.
** Karl Fisher.
** Polarimeter

Personal Details :
Name : Swati Ganesh Kale.
Total Experience : 8.5 yrs.
Date of Birth : 27th August 1983.
Gender :
Nationality : Indian
Marital Status : Married
Languages Known : English, Hindi, and Marathi.
Hobbies : Painting, Acting.

Declaration :
I hereby declare that all the information given above is true to the best of my knowledge and belief.

[Unregistered]

CURRICULUM VITAE
Nayana P. Jain
Email : neha9_june AT yahoo.in

CAREER OBJECTIVE :
To establish myself being a pharmacy professional in the corporate with my scientific and
Managerial skills for the benefits of the global healthcare system and of the organization.

AREA OF INTEREST :
Regulatory Affairs, Quality Assurance, Validation, Formulation and development (R&D).
INDUSTRIAL TRAINING :
Industrial training at “Matrix”/ “Mylan” pharmaceuticals, Sinner, Nasik on brief introduction of handling of equipment such as UV, IR, HPLC, PH meter, Dissolution apparatus, Roche friabilator, Tablet Hardness tester, Disintegration tester and brief introduction of working of machinery use in different department such as tablet compression machine, Blenders, Fluidizer, Roller compactor for granulation, Capsule filling machine, Packaging lines.

M.PHARM RESEARCH PROJECT :
(completed from Formulation and Development dept. of Unichem Laboratories Ltd., Mumbai)
“Formulation development & Evaluation of extended release pellets in capsules containing Antimuscarinic agent”.

ACADEMIC QUALIFICATION :
S. No. Qualifying Examination University/Board Year Percentage
1. M.Pharm
2nd year
(Quality Assurance) Pune University,
( MIT college of pharmacy, Pune) 2012-13 Waiting for result. (completed Research project work from Unichem laboratories, Mumbai)
2. M.Pharm 1st yr
(QualityAssurance) Pune University,
( MIT college of pharmacy, Pune) 2011-12 64.4% (1st sem)
71.4%(2nd sem)
3. GPAT NMU(North Maharashtra University), Jalgaon (Maharashtra). 2011 Qualified
4. B.Pharm :
(Final year) NMU(North Maharashtra University), Jalgaon
(H.R.Patel Institute of Pharmaceutical Education & Research, Shirpur .) 2010-11 74%

5. B.Pharm :
(Third year) NMU(North Maharashtra University), (H.R.Patel Institute of Pharmaceutical Education & Research, Shirpur .) 2009-10 75.50%
6. B.Pharm
(Second year) NMU(North Maharashtra University), (H.R.Patel Institute of Pharmaceutical Education & Research, Shirpur .) 2008-09 77.38%
7. B.Pharm :
(First year) NMU(North Maharashtra University), (H.R.Patel Institute of Pharmaceutical Education & Research, Shirpur .) 2007-08 70.94%
8. H.S.C. ( Higher Secondary) Nasik Board
(R.C.Patel Mahavidhyalay, Shirpur ) 2006-07 69.67%
9. S.S.C. (Matriculation) Nasik Board
(R.C.Patel Mahavidhyalay, Shirpur ) 2004-05 68.13%

PROJECT REPORT :
B.pharm final semester project report on “ Pharmacovigilance”

POSTER/SEMINAR PRESENTATION :
1. Poster presentation on “Heart transplantation” in 2007 at H.R.Patel Institute of Pharmaceutical Education & Research, Shirpur, Dist-Dhule.
2. Poster presentation on “Autism an orphan disorder ”in 2008 at H.R.Patel Institute of Pharmaceutical Education & Research, Shirpur, Dist-Dhule.
3. Poster presentation on “Innovations in pharma packaging” in MITCON institute National Conference pharmeet 2011 at Pune.
4. M.Pharm. First semester seminar presentation on “Implantable drug delivery system”.
5. M.Pharm. 2nd semester seminar presentation on “ ICH guidelines on impurities ”.
6. M.Pharm 3rd semester seminar presentation on “Formulation development & Evaluation of extended release pellets in capsules containing antimuscarinic agent”.

CONFERENCE ATTENDED :
1. Attended “IPC” 2008 which is conducted in Delhi.
2. Participated in MITCON institute National Conference “Pharmeet” 2011 at Pune.
3. Attended one day workshop on “Trends in HPLC Techniques” MAEER’s MIT
4. Attended two day conference on “Innovative Drug Delivery System”.
SOFTWARE PROFICIENCY :
Proficient in using Operating Systems and programs like MS Office, MS-DOS, MS Windows, ChemOffice, Chemdraw, making presentations, Scientific information retrieval using search engines and Patent databases on various internet portals..

KNOWLEDGE SPECTRUM :
- Quality Assurance, Drug Regulatory Affairs, Validation, Intellectual Property Rights.
EXTRACURRICULAR ACTIVITIES :
- Active participation in various cultural and sports events during graduation and post graduation level.
- Attended “Bhartiya Chatra Sansad” at MAEER’s MIT college, Pune.
- Attended “Graduate Grooming Programe” at MAEER’s MIT college, Pune.

PERSONNEL DETAILS REFERENCE :
- Date of Birth : 8th June, 1990 Dr. B.S.Kuchekar(Principal)
- Gender : Dr.A.P.Kulkarni(project guide)
- Languages known : English, Hindi, Marathi. MIT college of Pharmacy,
- Hobbies : Reading, Painting, Playing brain game Kothrud, Pune.

DECLARATION :
I hereby, solemnly declare that all the information provided here is as per the best of my knowledge.

Place : Mumbai
Date :
(Nayana Jain)

[Unregistered]

NISHA DESAI
nishadesai21 AT gmail.com

SUMMARY :
Over 2.4 years of experience in the Quality Assurance segment of the Pharmaceutical Industry with an expertise in QA, QC, and Process Documentation. And 2.4 years experience in regulatory affairs.

EMPLOYMENT HISTORY :
Biochem Pharmaceutical Industries Ltd., Mumbai (Zydus Cadila) FEB 2011 – TILL DATE
Biochem Pharmaceutical Industries is one of the leading Pharmaceutical manufacturers that is engaged in the research, development, manufacturing and marketing of pharmaceutical products.

Position : Executive
ROLES & RESPONSIBILITIES :-
1) Preparing product registration dossiers for countries (Myanmar, Senegal, Srilanka, Nepal, Algeia, Nigeria, Sudan, Thailand, Malaysia, Dominican Republic, Guyana, Cuba).
2) Remark & compile new product development as per the guidline of the new countries.
3) Attending Queries related to product registration.
4) Arranging commercial documents (COPP & FSC) and samples for registration.
5) Tender related documents & sample.
6) Checking & Approve the Certificate of Analysis for the Finished & active raw material
For the all export going shipments.

Packaging material :
1) Developed new artwork (carton, label & Packing insert) for export as per country
Requirements.
2) Initiate for the development of packing insert for the new products.
3) Arranging for the printed packing material (carton, label & packing insert) for
Product registration

Registration Status :
1) Prepare country wise & product registration chart.
2) Follow with the foreign party’s for registration status for product which is under
Registration.
3) Master file for Country wise product Registration Details along with Registration
Certificate / product specification.

Biochem Pharmaceutical Industries Ltd., Daman JUL 2008 – Nov 2010

Position : Quality Assurance Officer
ROLES & RESPONSIBILITIES :-
Quality Assurance Officer.
Handling and Calibration of DT and Friability apparatus.
Documenting BMR, MFR and QC Protocols.

Sidmak Laboratories (INDIA) Private Ltd., Valsad, Guj. DEC 2007 – JAN 2008
Sidmak Laboratories (India) Pvt. Ltd. is a pharmaceutical company having manufacturing facility at Gujarat, India.
Underwent a two month industrial training with complete exposure to QA, QC, Production and R&D function at their plant.

EDUCATIONAL QUALIFICATION :
B. Pharm 2003-2007 Rajiv Gandhi University of Health Sciences, Karnataka
H.S.C. 2003 Gujarat State Board
S.S.C. 2001 Gujarat State Board

PERSONAL DETAILS :
Date of Birth : 21st June, 1986
Marital status : Married