www.clarislifesciences.com Claris Lifesciences Ltd Ahmedabad : Fresher Regulatory Affairs

[mskavi]

Claris Lifesciences Limited Ahmedabad : Opening for Regulatory Affaris
Website: http://www.clarislifesciences.com
clarislifesciences.com

Job Description:

1. Preparation of registration dossiers and resolving queries for enabling business development in Regulated pharmaceutical markets

2. Coordination with Production, Research and Quality for timely Regulatory submission

3. Verification of Dossiers and Marketing Authorization Application (MAA) for correctness and data integrity

4. Solving queries by regulatory authorities and promptly replying in given time frame

5. Upgrading knowledge in line with ever changing regulatory requirements

6. Documents check for Dossiers

7. Preparation of Technical package

8. Work on GFD Products

9. Applying for COPP & Product Permission

Desired Candidate Profile:
1. Excellent communication and presentation skills

2. Knowledge in basics of ANDA, MHRA and other regulatory guidelines

3. Knowledge of submissions through MRP, DCP , National Procedures

Qualification:
B Sc / M Sc / B Pharm
B Pharm / M Pharm with 2 years exp
Freshers can apply

Interviews shortly within this week

Address:
Claris Lifesciences Limited
Corporate Towers, Near Parimal Railway Crossing
Ellisbridge
AHMEDABAD,Gujarat,India 380006

Telephone: 91-79-26563331

Apply here

[rakesh222@yahoo.com]

I am a fresher. i am interested for above mentioned post for the job

[Guest]

where is your maharashtra head quater

[Guest]

Respected Sir,

I Patel Mayank D From Gujarat, studing at Acharya college of pharmacy at Bangalore in second year and i already completed my project work on synthesis and pharmacological evaluatuon(Cancer and anti microbial) of piperazine substituted pyran derivatives. I am hardworking and i wants job as early as possible. so i am sending you my resume. Curricular vitae

Patel Mayank Dahyabhai
E-mail :- mayankijapura AT gmail.com
Contact No.
CAREER OBJECTIVE :-
- To give best contribution in the field of Pharmacy
- To seek bright career as a researcher.


ACADEMIC QUALIFICATION :- B.pharma final year i got 66.92% and in M.Pharma first year i got 78%, and i completed my project work.

PAPER PRESENTATIONS :-
- 61st Indian Pharmaceutical Congress (I.P.C) at Ahmedabad-2009


HIGHLIGHTS :-

- Hard working.
- Interested in Research.
- Good decision-making capabilities in any situation
- Familiar with MS office, Docking study(Molegro virtual docker softwere) and internet application

[Guest]

Saini jitendra ashok kumar

subject:application for the job of regulatory affairs.

personal details:
qualification:D-pharm with 70.50% in the year 2006
B-pharm with 70.00% in the year 2010.
from rajiv gandhi university of health science.

contact details: e-mail id: snjitendra852@gmail.com
saini_jitu@ymail.com
mbl no.

[shyamalpatel]

From
shyamal patel
Ahmedabad

To
Human Resourse department
Respected sir
I have completed my Bpharma in the year 2010 with 67% from Rajiv Gandhi Uni.
i worked 6 months in the well phama company in product development department. and i worked for the product permission related work in my last job.
I m intrested to work in your company.its a great opportunity for me if i get a chance to work in your company.

Thank you

[thakkardipti50@gmail.com]

Hello sir i m b.pharm fresher if u have any suitable post then reply me

[Guest]

Subject : An Application for the post of trainee chemist for Regulatory Affairs.
Respected Sir,
I have come to know from the reliable sources that there are some vacancies for the above mentioned post, on going through the Qualification required for the job, I put forth my self your required perusal.
I assure you that I will work with zeal and honesty and try my best level to give complete satisfaction in the work against to me.
Please find my detailed resume enclosed herewith.
CURRICULUM VITAE
Name : Mr. Mangesh Kashinath Patil.
E-Mail : patil.mangesh88 AT gmail.com
CARRIER OBJECTIVE :
Intend to acquire knowledge & making it fruitful implement & to make best efforts towards all kind of knowledge & skill & willing to learn & contribute to growing Organization.
PERSONAL STRENGTH :
- Excellent capacity to understand work in diverse condition.
- Strong ability to do work up to the mark.
- Ease to adopt change in working environment.
ACADEMIC CARRIER :
Exam Name of College Name of Board Year Of Percentage
Passed University Passing Obtained

M.Sc. Pratap College, Amalner NMU Jalgoan 2010-11 69.75%
BSc. Pratap College, Amalner NMU Jalgoan 2008-09 71.67%

COMPUTER COURSE :
MS-CIT
ROUTINE WORKS :

- Maintain all Log Books of Sophisticated instruments.
- Daily Calibration of Balance.
- Maintain all daily documentation.
Experience of 1 month for IPR department.

[nehabilimoria]

Ms. Neha Bilimoria - Tailor
Email : nehabilimoria AT gmail.com
---------------------------------------------------------------------------------------------------------------------
Career Objective :
To find an exigent job in the industry where my intelligence, skills, dedication, hard work and perfection would yield mutual exponential development.
Experience :
About two year of total working experience including Professional (Technical) and Research.
Current company :
I Company Konduskar Laboratories Pvt Ltd, Kolhapur
DURATION : November 2009 – January 2011
I was working as Regulatory Officer with Konduskar Laboratories (Sister Concerned of KAMUD DRUGS PVT LTD, SANGLI) an API manufacturer.
Reporting to Head Quality
Responsibility & Achievements :
- Ensuring that a company's products comply with the regulations of the Medicines and Healthcare products Regulatory Agency (MHRA).
- Preparing ASMF (AP, RP, QOS) as per CTD independently
- Responsible for the maintaining of the regulatory documents like annual updates, revisions, variation etc.
- Preparing submissions of license variations and renewals to strict deadlines.
- Preparation of US & EU DMF according to ICH guidelines.
- Monitoring the progress of regulatory submissions, responding to queries and ensuring that registration approvals are granted with given time limits.
- Submitting of online CTD according to ICH guidelines.
- Dealing with the customer complaints and resolving the problem within proper time frame.
- Keeping abreast of international legislation, guidelines and customer practices.
- Negotiating with regulatory authorities for marketing authorization.
- Good knowledge of ICH guidelines.
- Keeping update with regulatory norms of Medicines and Healthcare products Regulatory Agency (MHRA), the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) etc.
II Company National Toxicology Centre, Pune
DURATION : November 2008 – October 2009
Worked as a Research Assistant and involved in pre clinical studies.
Reporting to Director :
Responsibility & Achievements :
- Microbiological testing of samples (New Drugs, effluent, potable water, surgical devices, biopesticides, food products) by using techniques.
- Performing Bioburden tests.
- Toxicity testing using animal models like Rats, Mice and Rabbits.
- Raising of polyclonal antibodies from rabbit sera.
- Quantification of antibodies produced; by ELISA method.
- RNA extraction from rabbit blood.
- Perform cytotoxicity studies invitro and invivo.
- Ecotoxicity in soil microflora, fresh water fish (Guppy), fresh water algae.
- Reticulocyte count of blood sample for Bioassay of a drug.
Instruments handled :

- U.V. Spectrophotometer (Chemito Spectrascan 2600, Double beam).
- Biochemistry Analyzer.
- Haematology Analyzer (Diatron).
- Refrigerated Centrifuge (Eppendorf).
- Colony counter.
- ELISA Reader.
- Inverted Microscope.
Education & Professional Qualification :
MASTER OF SCIENCE (MICROBIOLOGY) :
Mumbai University from K J Somaiya College of Science and Commerce, Mumbai in year 2008.
BACHELO OF SCIENCE (MICROBIOLOGY) :
Shivaji University, Kolhapur from Rajaram College in year 2006.

Project :
TITLE :
Isolation and Identification of Whey degrading yeast so as to reduce its BOD and COD.
The study included isolation of yeast from whey itself and from soil surrounding Dairy that reduced BOD and COD value and bring in range that is needed by Pollution Control Board. Other parameters like TVC, TSS, TDS were also studied.

Training :
- A two weeks training at Gokul Dairy, Kolhapur in Quality Control Department.
- Worked as a trainee in various Department of Seth G.S. Medical College and Hospital, Parel, Mumbai for one week.
Paper Presentation :
- Second prize in Intercollegiate paper presentation on “Biosensors” in Biovision Club, Rajaram College, Kolhapur.
- Participated in Intercollegiate paper presentation on “Pyruvate- A key intermediate in Carbohydrate Mechanism.” In Dolphin group, Yashvantroa Chavan Institute of Science, Satara.
- Participated in poster competition in Microscope Intercollegiate Event, K. J. Somaiya College, Mumbai.

Extra-curricular Activities : -
1. Participated in workshop of “Kuchipudi” dance.
2. Participated in workshop of “Bharatnatyam” dance.

[Guest]

Subject : Application for the post of suitable position.

Respected Sir,
With due regards, I would like to represent myself as an applicant in your organization for above mentioned post. For the purpose, I have enclosed my detailed resume for your kind consideration.
My result oriented efforts & willingness of growing faster by achieving the goals of the organization will make me successful on the practical field of Pharmacy.
I would like to prove my technical skill if given an opportunity to work with your organization.
Eagerly waiting for your favorable reply.

RESUME
Sunil.M.Amin
E-MAIL :aminsunil AT rocketmail.com

Objective : To seek entry level position in an organization, where my acquired technical skills would help to achieve the goals of the organization, making both, the organization and myself successful.

EDUCATIONAL QUALIFICATION :
Diploma Pharmacy part-I (Gujarat university) May 2005 (P.C.I. Approved) 60.04%
Diploma Pharmacy part-II (Gujarat university) April 2006 (P.C.I. Approved) 58.70%
Degree Pharmacy part-II (Gujarat University) April 2008 57.17%
Degree Pharmacy part-III (Gujarat University) April 2008 62.00%
Degree Pharmacy part-IV (Gujarat University) April 2009 58.00%

Computer Literacy : BASIC, INTERNET.

EXPERIENCE :
Experience of production and packing both.
- As a packing officer in sun pharmaceuticals ltd at halol plant.3rd march to till date.parenteral,tablets,soft and hard capsules.
Handling medicine & bulk filling in a bottle.(ace packer machine,countec machine)
= As a production officer in a Briyosis soft caps pvt. Ltd. (WHO GMP certified company) from june 2010 to march 2011
Working in a medicine deparment,gelatin preparation,encapsulation, packing department.
filling B.M.R,B.P.R,Handling encap 202,303,292 machine,pam-pac blister machine,pam-pac alu-alu pack machine,AF-40(fully automatic capsule filling machine,making S.O.P,labour management,printing inner and outer carton
= Worked in Relax pharmaceuticals as a trainee for three months for production of tablets.
As a pharmacist in metro hospital for 1 year .
As a medical representative in medimerck pharmaceticals

EXTRA CURICULAR ACTIVITIES
» GOT 185TH RANK ALL OVER GUJARAT IN BACHELOR ENTANCE TEST.
» PARTICIPATED AT BABARIA INSTITUTE (AHVAN 08) AT NATIONAL LEVEL TECHNICAL FIESTA AND ALSO ATTENDED PHARMAFEST HELD AT PARUL INSITUTE OF PHARMACY.
»VISITED INDIAN PHARMA COUNCIL AT DELHI (2008) AND AHMEDABAD (2009)
»HAVING EXPERIENCE AS A TRAINEE PHARMACIST IN JAMNAGAR (GG GOVERMENT HOSPITAL) FOR 3 MONTHS. BEING REGISTERED AS A REGISTERED PHARMACIST AND HAVING LICENCE ALSO.

FACED THE WHO GMP AUDIT,CADILA AUDIT FOR SEX HORMONES PRODUCTION,PIRAMAL HEALTHCARE AUDIT FOR ITS PRODUCTS HANSEPRAN-50&100 CAPSULES, ABOTT AUDIT, INSPECTION OF DRUG INSPECTOR FROM FDL-VADODARA IN BRIYOSIS SOFT CAPS PVT LTD.
FACED USFDA AUDIT IN SUN PHARMACEUTICALS INDUSTRIES LTD,HALOL.

[Guest]

I have completed my MSc in Biochemistry from the University of Pune. I am currently working with the Developmental Quality Assurance Dept for a leading Biotech Company. I am interested in the above mentioned job profile. Kindly do let me the procedure of applying for the same.
Regards,
Shruthi
shruthi.bala AT gmail.com

[Guest]

Respected sir/Madam,
Below is my CV for regulatory affairs dept.
I would be glad to serve your organization,
thanking you,

DARSHAN M MODI
Email ID : darshanmodi AT live.com

OBJECTIVE
To contribute to a pharmaceutical company, that serves the needs of a diverse patient population. Looking for challenging career, where there is scope for utilizing my skills and abilities that offers professional growth and gives opportunities for updating my knowledge while being practical and resourceful.

EDUCATIONAL BACKGROUND
PHARMACY
- Carried out Project training at INTAS BIOPHARMACEUTICAL Pvt. LTD. in ADL(Analytical development lab).
Course School/College Board/University Academic year Class Percentage
M.Pharm(I-year) Pacific college of pharmacy Pacific university 2010-2011 First 62.50%
M.Pharm(II-year) Pacific college of pharmacy Pacific university 2011-2012 Awaited Awaited
Course School/College Board/University Year of passing Class Percentage
B.Pharmacy Karnataka college of pharmacy, Bidar. Rajiv Gandhi university of health sciences, Karnataka. September, 2010 First 65.83%
PRE -PHARMACY

H.S.C Gujarat Board MARCH-2006 SECOND 57.85%
S.S.C. Gujarat Board MARCH 2004 DISTINCTION 76.71%
ACADEMIC RECORD :-
B.Pharmacy
University : Rajiv Gandhi university of health sciences, Karnataka.
College : Karnataka college of pharmacy, Bidar.
Aggregate : 62.58%
Computer Proficiency
- M.S Office
- Internet
- HTML
Extra- achievements
- Won first prize in 1500 mts race at college sports day.
- Participated in Gujarat district level athletics competition.
Strength

1. Adapt to new environment easily.
2. Strong decision-making.
3. Efficient communication.
4. Commitment to the task.
5. Can mix up with different group of individuals without much difficulty.
6. Believe in teamwork

[kajalpatel9931@gmail.com]

To,

HR department ,

Subject : Application for a post of Drug Regulatory Affair Dept.

Respected Sir,
I, Kajal S. Patel, pursuing my M. Pharm (Quality Assurance) with distinction from R.C.Patel Institute Of pharmaceutical Education & Research, Shirpur, Maharashtra. For better career opportunity, I am forwarding my application for the post of Drug Regulatory Affair Dept .
I kindly request you to consider my application for a post in this well-established Organisation. I am attaching my resume and attested document here with.
Thanking you.
Yours Sincerely,
Kajal patel
CURRICULUM VITAE
KAJAL S. PATEL

E-mail Id- kajalpatel9931 AT gmail.com

Career Objective
To pursue a successful career in Regulatory affairs with well established institution, which enhance and value my talent, knowledge & experience for personal and organizational growth.
Area of Interest
International Regulatory Affairs
ADL
Bio- ADL
Experience
One month training experience in Indica Laboratories Ltd. At Ahmedabad.
Three months training experience in Civil Hospital. At Visnagar as a dispensing pharmacist.
Five months training experience in Bio Analytical department & 2 months training experience in Analytical Department at Zydus Cadila, Moraiya.
Work Experience Detail
Handling of U.V., FTIR, pH meter, Flame photometer, Conductometer, Dissolution apparatus, Auto-diluter, HPLC, partial handling.of LC-MS/MS.
Calibration of Micropipette.
Calibration of Analytical Balance.
Calibration of pH meter.
Development of sample for LC-MS/MS technique by Protein precipitation, Liquid-Liquid extraction, Solid Phase extraction.
Handling of Micropipette, Centrifuger, Evaporator, and Vortexer.
Skills
Good communication skill (in English, Gujarati, Hindi & Marathi ) & ability to build effective relationship with trial site staff & colleagues.
Computer Skill – Proficient in Microsoft office (word, excel & PowerPoint) Internet, expertise in using search engines such as google, Pubmed, science direct.
Symposia Attended
I have attended seminar on “N.M.R” At R. C. Patel Institute of Pharmaceutical Education & Research, Shirpur.
I have presented a poster on ICP-MS in pharmafest-11, Baroda college of Pharmacy, Baroda.
Professional Skills
Time driven, willing to work hard efficiently
Trustworthy, enthusiastic to know newer things
Comfortable to work in team
Academic Credential :
Institute/Organization Board/ University Year Percentage
M.Pharm,Q.A
(3rd sem.) R. C. Patel Institute of Pharmaceutical Education & Research, Shirpur. North Maharashtra University Jan-12 Grade-A
M.Pharm,Q.A
(2nd sem.)
R. C. Patel Institute of Pharmaceutical Education & Research, Shirpur. North Maharashtra University May-11 73.4%
M.Pharm,Q.A
(1st sem.)
R. C. Patel Institute of Pharmaceutical Education & Research, Shirpur. North Maharashtra University Jan-11 72% (3rd rank)
B.Pharm Nargund College Of Pharmacy, Bangalore-85. Rajiv Gandhi University Of Health Science, Bangalore. Dec-09 78.25%
(1st rank)

Declaration :
I Kajal S. Patel hereby declare that all the entries are correct to best of my knowledge.
Date : 06/03/12
Place : Ahmedabad Signature: Kajal S. Patel

[Guest]

RESUME
Niki S.Dudhia
M.Pharm (Clinical Pharmacy)
Email : nikimodi_87 AT yahoo.co.in
Career objective :
- Seeking a challenging career that utilizes my skills and enables me to serve the goal of the Organization.

Academic Records :
I has been complete M.pharm (Clinical Pharmacy) from Shri Sarvajanik Pharmacy College, Gujarat Technological University with 8.23 CPI in 2011.

Academic Thesis :
B. Pharm Thesis- 2009
Title : Urolithiasis
Guide : Prof. Prasanna K.Pradhan
M.Pharm Thesis- 2011
Title : Comparative study of efficacy & safety of Clopidogrel versus Prasugrel in patient with acute coronary syndrome.
Guide : Dr. I.S.Anand
Place : Lifecare institute of Medical Sciences and Research, Ahmedabad
Areas of Interest :
- Clinical Research
- Regulatory Affairs
- BA/BE Studies
- Pharmacovigilance
- Quality Assurance
Publication of papers in journal :
International :
1. Ivabradine-If Inhibitor : An Overview published in International Journal of Advances in Pharmaceutical Research [ISSN 2230-7583] – Review Article
2. “Comparative Study of Efficacy and Safety of Clopidogrel Versus Prasugrel in
Patient with Acute Coronary Syndrome” : accepted in International Journal of
Pharmaceutical Research (IJPR) [ISSN No 0975-2366]- Research Article
Work Experience :
- I have worked with Lifecare institute of Medical Sciences and Research, Ahmedabad as part of M.pharm Dissertation and also involved in clinical research related activities like screening and randomization, IVRS/IWRS, Inform consent Process, subject visit schedules, IP dispensing and accountability and other trial related activities.
- At present, I have been working as a lecturer with Shivrath COE in clinical research (A joint venture with Gujarat State Biotechnology Mission, DST Govt. of Gujarat) Thaltej ,Ahmedabad.
Other Academic Achievements :
- I have been qualified in GATE examination (March 2009) with 81.72%
Extra-curricular activites :
- Attend national seminar on Regulatory and industrial perspective on GMP and GLP in India vis Developed Countries, Held at Shri Sarvajanik Pharmacy College, Mehsana in 2010.
- Participate as a volunteer in 61th INDIAN PHARMACEUTICAL CONGRESS, Held at Nirma University, Ahmedabad in 2009.
- I have attend seminar on ICMR sponsored “One Day Workshop on ICH-GCP training”, Held at Gujarat University ,Ahmedabad on 6th Aug 2011.
Key skills :
- Basic computer knowledge of Microsoft Office.
- Operating Systems known- Windows-2003, XP, XP- Ultimate and Vista.
- BA/BE knowledge (updated till recent amendments) as per CFR-21.
- Good interpersonal relationship and research orientation.
Hobbies To meet different people, reading , music
Strengths Strong will power, positive attitude, strategic thinking, stamina, adaptive nature with any environment, flexibility, curious & keen to learn new things.

Declaration :
I hereby declare that the above-mentioned information is true to the best of my knowledge.
Niki S. Dudhia

[Unregistered]

Personal Details- qualification- D.Pharm with 66.9 in the year 2009
B.Pharm with 70.1 in the year of 2012.
From ssscp,Kalol. gtu.