www.svshome.com SVS Life Science Ltd Hyderabad : QA API Regulatory Affairs

[mskavi]

SVS Life Science Pvt Ltd Hyderabad / Secunderabad : Manager - Regulatory Affairs
Website: http://www.svshome.com

Keywords: Consultancy Services

Designation: Manager - Regulatory Affairs
Experience: 10 - 12 Years
Location: Hyderabad / Secunderabad
Compensation:
Rupees 8,00,000 - 10,00,000
Education:
UG - Any Graduate - Any Specialization
PG - Any PG Course - Any Specialization
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Healthcare, Medical, R&D
Posted Date: 08 Aug 2009

Job Description:

To prepare dossiers in eCTD formats
To proceed for filing in regulated markets as per procedures
Conduct 3rd party cGMP audits in pharma facilities.
To develop documentation for implementation of different quality systems.

Desired Candidate Profile:

Professional with 10 to 12 years of total experience in the pharma industry.
Should be currently working for the last 2 to 3 years in area of Regultory Affairs.

Should have past exposure in QA with API manufacturers.

Company Profile:
SVS Life Sciences is a services company, founded in 1994 in Barcelona (Spain).

A specialized- services company in the technological sector offering global solutions exclusively for the Life Sciences Industry.

Experts in providing Consultancy, Regulatory Affairs and GXP Compliance Services.

We handle projects worldwide, thanks to our internal organizational set up spread over in Asia, Europe , Latin America, North Africa and Middle East.

Composed of over 200 professionals.

SVS established its Indian Head Office in Vashi, Navi Mumbai under the name of SVS Life Sciences Private Limited in April 2008.

This was followed by opening of another office in September 2008 at Hyderabad.

A total of 10 professionals are currently employed at SVS India.

Executive Name: MR. Sarang V. Mulay

Address:
Not Mentioned

Email Address: sarang.mulay@svshome.com

Telephone: Not Mentioned

Keywords: Consultancy Services

[Guest-IJT]

ARGHYA BISWAS. M.PHARM (Pharmacology)

Address: C/o. Siddappa,
House No. 1078, Mobile: 09844686856
3rd B Main Road, E Block, 2nd Stage, E-mail: biswas.arghya@gmail.com
Rajajinagar, Bangalore-560010 biswas.arghya@ymail.com



Career objective:

Seeking a position to utilize my skills and abilities in the Industry that offers professional growth while being resourceful, innovative and flexible.


M.Pharm. Academic Project

Project Title: “Study Of Cardiovascular Effects of Thiazolidinedione Anti-Diabetic Agents in Experimentally Induced Heart Failure and Hypertensive Rats.”

Brief Overview of Project: The objective of our project is to determine the effect of Rosiglitazone and Pioglitazone on High Fructose Diet induced hypertensive as well as Isoproterenol induced heart failure rats. The work requires long term recording of blood pressure using non-invasive technique, estimation of different bio-chemical parameters using semi auto-analyzer and recording of ECG.

Contribution:
- Review and selection of animal disease models.
- Preparation and execution of test plans.
- Optimization of the tail cuff method for blood pressure measurement in rats.
- Involved in end-to-end activities of the whole study.
- Identification and resolution of problems during study.

B.Pharm. Academic Project

- Patient Case history study from North Bengal Medical college &
Hospital, West Bengal-7 days
- OTC drugs sale & Schedule-N Compliance of a Pharmacy Store from
Uma Agency- Chemist & Druggist, Jalpaiguri, West Bengal-7 days


Technical Skills:

RESEARCH SKILLS
- Expertise in animal handling and invivo and invitro experiments.
- Screening of drugs for cardiovascular diseases.
- Blood pressure measurement by non-invasive tail cuff method
(NIBP, ADInstruments).
- Isolated Heart experiment using Langendorff’s apparatus.
- Computerized measurement of ECG.
- Knowledge in ICH & GCP Guidelines.
- Knowledge in Clinical Trail.
- Knowledge in Double Beam Spectro Photometer (Shimadzu).


COMPUTER SKILLS
Operating System : MS DOS, WINDOWS 98/XP.
Software : MS Office*, Linux*, HTML*, MS Access*,
Graphpad.
Exposure to : Adobe Photoshop, Corel Draw.
*Completed course from NIIT


Education:


Examination Institution University Year of Passing Percentage
M.Pharm
(Pharmacology) Al-Ameen College of Pharmacy, Bangalore R.G.U.H.S 2009
72.50

B.Pharm.
Himalayan Pharmacy Institute, Sikkim University of North Bengal 2005 73.29


Academic achievements/activities

- Poster presentation titled “Hyrdoalcoholic root bark extract of Salacia oblonga reduces Mitomycin-C induced sperm abnormality in wistar rats.” in International Herbal conference, Bangalore,26-28 February 2009.
- Attended workshop on “Research Methods and Scientific Writing”,13-14 December 2008
- Attended National workshop on “Effective Thesis Writing and Career Prospects in Pharmaceutical Sciences”,25-26 June 2008
- Visited “Natural Remedies Pvt. Ltd.”, Bangalore, 20 March 2008
- Attended workshop on “Getting Started in Research”, 21 November 2007
- Attended I.P.C (Indian Pharmaceutical Congress), 2004, Kolkata.

Memberships:

- West Bengal state Pharmacy Council – Registered Member.
- Association of Pharmaceutical Teachers of India (APTI) – Life member
- InPharm Association- Life member

Interests and Hobbies:

- Travelling, Cricket, Listening to Music and Handwriting Analysis.
- Interested in coordinating events like college fests, National Pharmacy Week celebration, workshops and seminars.

Personal Details:

Strengths:
- Excellent communication skills
- Enthusiastic and Hardworking with strong Intellectual skills
- Self Motivated & an Excellent Team Player
- Aptitude in analyzing Data and Literature

Sex & Marital Status: Male & Unmarried
Date of Birth : 4th January, 1983.
Nationality / Citizen : Indian
Languages Known : English, Hindi, and Bengali
Permanent Address : C/o. Arun Kumar Biswas,
Durgabari more, Maynamapara,
P.O. Maynaguri, Dist. Jalpaiguri, Pin. 735224.
West Bengal. Phone-03561-233088

[Guest]

CURRICULUM VITAE

MANASA RACHARLA,
E-mail :manasarrr AT gmail.com

Objective
To seek the position in a reputed organization where I could put into practice my innovative creative skill for the mutual benefit both for organization and me so as to have a promising future.
Academic Profile
- Master of Pharmacy in Pharmaceutical Analysis in Oil Technological Research Institute,JNTUA with 81.6%. Major project has been carried at Dr.Reddys laboratories, Hyderabad.
- Bachelor of Pharmacy from Rao’s College of Pharmacy, Affiliated to Jawaharlal Nehru Technological University with an aggregate of 76%, Year 2005-2009.
- Intermediate from Sri vema Junior College with 85.6%, Year 2002-2004.
- S.S.C (10th class) from Z.P.High school with 80.50%, Year 2002.
Technical Proficiency
Capable in handling
- UPLC (WATERS AQUITY),
- HPLC (AGILENT 1120),
- UV – Visible Spectrophotometer (SYSTRONICS 117),
- Karl – fisher titrator,
- Flame photo meter, (SYSTRONICS),
- Colourimeter (SYSTRONICS),
- Nephelo and Turbidometer,
- Potentiometer and Conductometer. (SYSTRONICS),
- Dissolution apparatus (DISSO 2000, LAB INDIA)
Project works
- Performed major project in M.Pharmacy entitled “ RP-UPLC METHOD DEVELOPMENT AND VALIDATION OF HYDROCHLOROTHIAZIDE”.
This work has been done at Dr.Reddy’s laboratories. ( eight months inhouse project)
Project Description : The objective of reducing analysis time and maintaining good efficiency, there has been substantial focus on high-speed chromatographic separations. In this work, rapid, precise and specific ultra performance liquid chromatography (UPLC) method has been developed and validated for the determination of hydrochlorothiazide in an tablet dosage form. Isocratic chromatography was performed on a HSS T3 column with ACN: KH2PO4 of pH-3.5 (50:50, v/v) as mobile phase, at a flow rate of 0.4 ml/min, and UV detection at 272nm. Run time for analysis is 4 min , % recoveries were between 98 and 102%. The method was linear (r2 = 0.9993), and precise. It was also validated for specificity and robustness based on ICH guidelines. The proposed method is a good approach for obtaining reliable results and found to be suitable for the routine analysis of Hydrochlorothiazide in pharmaceutical formulation.
- Performed mini project in entitled “STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF DOXOFYLLINE”.
- Performed major project in B.Pharmacy entitled “ RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF ASPIRIN TABLETS”.
Publications :
- Stability indicating RP-HPLC method development and validation of doxofylline, R. kumanan, R. manasa and M. jitendra reddy, Int. J. Chem. Sci. : 9(1), 2011, 337-352 , ISSN 0972-768X.
Areas of Interest :
- Research & Development
- Regulatory Affairs
Computer Exposure
- Platform : Windows XP.
- Software : Ms Office, Acrobat, Photo shop.
Extracurricular activities
Singing , Participating in social and cultural functions.
Strengths
- Interested in learning new skills.
- Ability to work well under extreme pressure.
- Easily adaptive to new environments.
- Dedication towards work.

[Guest]

M.SADANANADA REDDY

Email : sadareddy18 AT gmail.com
OBJECTIVE : Aim to be associated with a Progressive organization that gives me the scope to share my knowledge and skills in accordance with the latest trends and be a part of team that dynamically works towards the growth of organization and gives the satisfaction thereof.
STRENGTHS : - Self motivated Dedicated and willing to work hard to achieve success
- Always trying to learn new and update my Knowledge
- Highly adaptable & flexible.
ACADEMIC PROFILE :
- Masters of Sciences [Biotechnology] from UNIVERSITY COLLEGE OF SCIENCE, OSMANIA UNIVERSITY. With Average GPA 9.13/10 in first two semesters, Awaiting results of 3rd & 4th semesters.
- Bachelors of Sciences [Bio Technology, Bio Chemistry, Chemistry] from Bhavan’s Vivekananda College, Osmania University during 2006-2009 with 79%.

- Intermediate (equivalent to 12th standard) with an aggregate of 90.4% in the year 2005 from Board Of Intermediate Education, Andhra Pradesh.
- S.S.C from KAKATIYA HIGH SCHOOL, Nizamabad, A.P, with 88% in the year 2003.
EXTRA-CURRRICULAR ACTIVITIES :
- Active participation in all kinds of games and cultural activities.
- Won many appreciation certificates at school level
- Won prizes for Essay writing, quiz competition, Elocution and Drawing.
PROJECT DETAILS :
Analytical study on the effect of physiological pH and Temperature on Ciprofloxacin, its degradation and stability by HPLC method.

[Guest]

CURRICULUM-VITAE
SUDHEER.PITCHIKALA
Email :sudheerchowdary.pitchikala7 AT gmail.com

ACADEMIC QUALIFICATION

COURSE INSTITUTION/ BOARD/ UNIVERSITY YEAR PERCEN
-TAGE
S.S.C. Z.P.H. HIGH SCHOOL,ANANTAPALLI.
2004 61.00
INTERMEDIATE A.K.R.G. JUNUIOR COLLEGE, NALLAJERLA. 2006 58.00
B.S.C A.K.R.G.DEGREE COLLEGE, NALLAJERLA. 2009 70.00
M.Sc. M.VR PG COLLEGE, VISAKHAPATNAM. 2011 66.00

COMPLETE M.Sc. IN BIOCHEMISTRY FROM M.V.R PG COLLEGE AFFLIATED BY ANDHRA UNIVERSITY, VISAKHAPATNAM.

SUBJECTS OFFERED DURING M. Sc. COURSE
Biochemistry, Molecular Biology, Microbiology, Immunology, Biostatistics, Bioinformatics, Genetics, Cell Biology, Enzymology, Plant biotechnology, Animal biotechnology, Biochemical Techniqes&Productions.
RESEARCH / OTHER EXPERIENCES
M. Sc. Dissertation work
Title : “EFFECT OF ABIOTIC STRESSES ON DIFFERENT CROPS”

Duration : 02 Month
Place : “CENTRAL TOBACCO RESEARCH INSTITUTE”RAJAMUNDARY

Thesis Advisor : Sr.Scinentist Dr M.ANURADA


COCURRICULAR ACTIVITY
- Operational proficiency and skills on analytical instruments
- Good working hand in Basic molecular biology technique (Genomic DNA isolation from fungus and bacteria, plasmid isolation,Digestion,ligation, Cloning,Transformation,PCR.

- Detection and quantization of Nucleic acid and proteins using Gel Documentation system
- Protein biochemistry techniques including, SDS-PAGE, functional protein assays, fluorescence microscopy etc.
- Good handeling in microbiological and fermentation techniques.
.
- Bioinformatics skills acquired :
- Local and multiple alignments such as FASTA, BLAST, Clustal W, etc
- Computer and Software knowledge :
MS-OFFICE & Internet

[Guest]

Hello sir/Madam
I am prathibha.B.working as a Q.A Executive at YM DRUGS from Aug 2007 Onwards.
With Regards,
Prathibha.B

[Guest]

CURRICULUM VITAE
ABISHEK SHREE. S.P
OBJECTIVE

Conscious in updating, finish work in time, generating new thoughts with old knowledge, view and approach in new way, spontaneous and sportive efforts make all things happen.
Interested in Molecular Modeling, Structural Genomics and interested in programming for tool development and database development and design.
ACADEMIC CHRONICLE
- 2009 M.Sc., Bioinformatics – 75.5% Bharathidasan University, Trichy, TamilNadu.
- 2006 B.Sc., Bioinformatics - 66% NI College of arts and science, Kumaracoil, Nagercoil, TamilNadu.
- 2007 Diploma in Biochemical Analysis- 73% Manonmaniam Sundaranar University.
COMPUTER SKILLS
- Operating System : Windows-98, 7/XP, vista, Linux (Ubuntu, Fedora, Centos).
- Programming Languages : C, C++, R and Java.
- Scripting tool & language : HTML, PERL, Mysql and Visual Basic.
AREAS OF INTEREST

- Cell Biology & Genetics
- Molecular Biology & Genetic Engineering
- Molecular Modeling & Drug Designing
- Structural Genomics
- Programming for Tool Development & Database Development
- Computational Biology
- Proteomics & Genomics
- Structural Bioinformatics
LABORATORY SKILLS

- Biochemical techniques
- DNA & RNA isolation techniques
BIOINFORMATICS SKILLS
- Molecular Visualization tools(Swiss PDB viewer, Rasmol, Read Mol Pymol,)
- All Basic Databases & Tools
- Geneious Pro
- Macro Molecular Deciphering
- EMBOSS
- Modeller
- Docking(Hex & Argus lab)
- Mol Inspiration Tool
- Discovery Studio
- TSAR
- MATLAB
- Support Vector Machine (SVM)
MINI PROJECT :
- I had done a mini project in INSILICO MODELLING OF GAMMA NAEMOLYSIN FROM METHICILLIN RESISTANCE STAPHYLOCOCCUS AUREUS (MRSA).
MAIN PROJECT :
- I had completed my main project in STRUCTURAL ANALYSIS OF RNA MOTIFS AND A NEW MAPPING RULE FOR RNA SECONDARY STRUCTURES & THEIR ANALYSIS.
PARTICIPATION & ACHIEVEMENTS

- Participated in APBC-2010 INTERNATIONAL CONFERENCE, in Indian Institute of Science, Bangalore.
- Participated in Workshop on BIOINFORMATICS TOOLS AND APPLICATIONS, in Vivekanandha College Of Arts & Science For Women, Elayampalyam, Tiruchengode (TK), Namakkal Dist. TamilNadu.
- Participated a National Conference in motif-2009 Conducted by Bharathiyar University, Coimbatore.
- Attended a Workshop in SUPPORT VECTOR MACHINE in Bharathidasan University, Trichy.
- Attended a National Seminar On STRUCTURAL BIOINFORMATICS in Manonmaniam Sundaranar University, Tirunelveli.
- Participated a National Symposium in “IN-SILICO & IN-VITRO STUDIES IN BIOLOGY” held in Holy Cross College, Tiruchirapalli.
- Participated in National Seminar On MICRO ARRAY TECHNIQUES Conducted By Jagsel Biosolution, Chennai.
- Presented a model presentation about Ames test in Kamaraj College of Arts & Science, Tuitucorin.

PERSONAL ATTRIBUTES :
- Ability to work as a part of a team as well as independently.
- Enthusiastic and always ready to learn new things.
- Ability to be productive under pressure.
- Good interpersonal and communication skills

- Reliable, efficient.