www.suryapharma.com Surya Pharmaceutical Ltd Chandigarh : Regulatory Affairs, Quality Assurance

[mskavi]

Designation: Vice President Quality Assurance & Regulatory Affairs
Job code: (VPQR:007)
Location: Chandigarh

Description:
The candidate should hold a degree in M.Sc/M.Pharma with 15-20 years experience in QA/RA out of which, at least 5 years should have been in a similar position. The candidate should possess a thorough understanding and obligation of all regulatory requirements in various global Pharma markets. The candidate should have the ability to significantly enhance Company's current level of compliance to match expected levels of compliance by regulatory bodies.

HEAD OFFICE
SURYA PHARMACEUTICAL
SCO-164-165, SEC-9-C, CHANDIGARH - 160 009, INDIA
+91-172 5005000
+91-172 5076000

DELHI OFFICE
911, 9TH FLOOR,
SURYA KIRAN BUILDING , 19, K.G. MARG,
NEW DELHI

www.suryapharma.com

[Guest]

Dear Sir/ Madam my self vaibahv i have completed B pharma and looking for suitable opening in QA RA IPR

[veera.mpharm]

Respected sir/madam,

I Veeraswamy Chitta completed mpharmacy(Pharmaceutical Analysis),so kindly give me an oppurtunity.

Thanking you Sir/Madam.

[Guest]

CURRICULAM VITAE
PERMANANT ADDRESS:
C/O Narpali Rafik Ramzan
Aftab Co-operative Housing Society,
E-Wing, 4th Floor, Room No. 402,
Amrutnagar, Mumbra-400612 (Thane) NARPALI ABDUL RASHID R.
Mobile No: 09016496884/09323694201
E-mail: rashid_narpali2005 AT yahoo.com
Objective:
- To be the part of determined and hardworking team in an organization where learning and innovation is continuous process and I can utilize myself as an asset.
Experience:
- May 2009 to Feb 2010 – Project Trainee in Astral Pharmaceutical Industries, Vadodara (Gujarat).
Summary: Thesis work done on Abbreviated New Drug Application of Cefoxitin for Injection (USP) as a Parentral Preparation.
Involved in each and every activity related to my Project work.
Taken exposure on formulation development on pilot scale.
Taken exposure of Equipment such as HPLC, GC, UV, K.F Titrator, TOC Analyzer, and Micro - Analytical Balance.
Taken Superficial Exposure on QC, QA, Production, Microbiology and Regulatory Departments.
- 13 June 2006 to 13 July 2006 – Industrial Training, Medley Pharmaceuticals Ltd, Daman (Gujarat).
Summary: Taken exposure of departments such as Production, QA, QC and Stores.
Education:
DEGREE BOARD/UNIVERSITY YEAR OF PASSING PERCENTAGE
M.Pharm (QA-I and II) Sumandeep Vidyapeeth 2009-2010 73.21 %
M.Pharm (QA-I) Sumandeep Vidyapeeth 2008-2009 71.16 %
B.Pharm (Final) University of Pune 2006-2007 67.12 %
H.S.C Gujarat Board 2002-2003 62.00 %
S.S.C Gujarat Board 2000-2001 83.71 %
Extra Qualification:
- March 2009 – Attended and Presented Poster in CDRI-NIPER Symposium on Medicinal Chemistry and Pharmaceutical Sciences, Central Drug Research Institute, Lucknow.
- Feb 2009 - Attended and Presented Poster in National Level Symposium for Pharmacy Students, Pharmafest-09, Parul Institute of Pharmacy, Vadodara.
- Feb 2009 – Participated in Elocution Compitition in National Level Symposium for Pharmacy Students, Pharmafest-09, Parul Institute of Pharmacy, Vadodara.
- Feb 2006 – Attended and Presented Poster in Interdisciplinary Sciences in Pharmacy (Symposium 2006), Smt. Sharadchandrika Suresh Patil College of Pharmacy, Jalgaon.
- 2007, 2006 – Second in Elocution Competition, Allana College of Pharmacy, Pune.
- 2005 – Winner in Elocution Competition, Allana College of Pharmacy, Pune.
- Nov 2001 – Secured 81.00 % in All India Senior General Knowledge Test, United Schools of Organization, New Delhi.
Skills:
- Basic computer knowledge (MS Office, Internet and Software).
- Good communication skills.
- Ability to work equally well either as part of team or on individual basis.
- Good command over English, Hindi, Gujarati and Urdu languages.
- Ability to work under stress and on priority basis.
- Good grasping power and ability to give innovative ideas.
Personal Information:
- Name : Narpali Abdul Rashid Ramzanbhai
- Marital Status : Single
- Date of Birth : 06 June 1985
- Gender : Male
- Nationality : Indian
- Passport No. : E7055433 Valid till 09 Oct 2013
References:
- Mr. Rajnikant Mistry ( Astral Pharmaceutical Industries, Vadodara) - 09723615767
- Mr. Ujjwal sahoo (Department of Phartmacy, Sumandeep Vidyapeeth, vadodara) - 09376939987

[Guest]

E u
CURRICULUM VITAE
Ashok Kumar B., M.Pharm. (Pharm.Chemistry). (PhD),
C/o Prof. Tapan Kumar Maity, Synthetic and Natural Chemistry Lab, Department of Pharmaceutical Technology, Jadavpur University, Kolkata -700032.
Hand Phone : +91-9051237788, 9477575789; Email: pacemaker08 AT gmail.com
UPersonal Profile
Name Ashok Kumar Balaraman
Father name Mr.R.Balaraman
Date of Birth 01-June-1980
Permanent Address No8, Koothiramedu, Musaravakkam po,
Kanchipuram, Tamilnadu - Pin : 631 501,
India.
Ph : +91-44-27294075 (Res.)
Nationality Indian
Religion Hindu
Languages Known English, Tamil & Bengali
Marital status Single
Current Research Summary
Currently as a Senior Research fellow, I am working on lead findings and optimization for diabetes, cancer and microbial diseases. I have gained a notable experience in isolation, characterization of the bio active molecules (by FT-IT, Mass and NMR and other relevant techniques) and pharmacological evaluation with smart handling of animals.
Key Responsibility
- Selection of plant, extraction, separation, isolation of active constituents and purification of the isolated constituents (TLC, CC).
- Characterization of compounds by UV, FT-IT, Mass, NMR (1H, 13C and 2D) and Elemental Analysis.
- Design and execution of experimental animal protocols for the evaluation of antidiabetic / anticancer/antimicrobial activities
- Identification, development and implementation of analytical procedures and methods for physical, chemical, and pharmacological studies. Also, data compilation and statistical analysis using specialized software.
- Coordination with various laboratories in taking part in the research activities.
- Training and assisting, M.Pharm students associated with lab research work, in laboratory experiments.
- Writing research proposals for various organizations for funding
Educational Profile
2BExam Passed 3BDiscipline 4BBoard / University 0B% Marks Year Passed 1BRemarks
PhD Pharmacy Jadavpur University,
Department of Pharmaceutical Technology, Kolkata
Thesis submitted
M. Pharm Pharmacy (Pharmaceutical Chemistry) Jadavpur University,
Department of Pharmaceutical Technology,Kolkata 76.00
2003 1 Class
B. Pharm Pharmacy The Tamilnadu Dr. M G R Medical University, Chennai 69.09 2002 1 Class
HSC Science and Maths Tamilnadu State Board Education 72.00 1997 1 Class
Professional Experience
2008 – Till date : UGC-Senior Research Fellow, Jadavpur University, Kolkata.
2005 – 2008 Worked as faculty in different pharmacy colleges
Projects & thesis work
Degree Title of Thesis
B. Pharm : Phytochemical and Anatomical Studies of the plant – Melothria maderaspatana (Cucurbitacea)
M.Pharm : Phytochemical and Biological Evaluations of fruits of Terminalia arjuna (combretaceae).
Current project Evaluation of certain isolated Phytochemical constituents from medicinal plants for anti diabetic activity against various models
Thesis Work Guided for Graduate Students’
- Evaluation of anti-diabetic activity of Terminalia arjuna at Pallavan Pharmacy College, Kanchipuram.
- Synthesis and pharmacological evaluation of indole containing amide derivatives. Anna University, Trichy.
Highlights of Research Experience and Skills Acquired
Chemistry part
- Isolation and characterization of bioactive constituents from natural products using classical and modern chromatography and spectroscopy techniques (FT-IT, Mass, NMR and Elemental analyzer) also having been involved in the interpretation of various spectra.
Pharmacological Part
Invivo models
- Acute, sub acute and chronic toxicity studies of isolated bioactive molecules and Synthetic compounds according to OECD guidelines.
- Evaluation of anticancer activity on against EAC implanted animal model
- Measurement of antioxidant activities in different in-vitro and in-vivo models.
- Studies on anti-inflammatory property of bioactive molecules and plant extract.
- Evaluation of preliminary Anti-diabetic activity of ethanol extract of Terminalia arjuna (Combretaceae).
Invitro models
- Studies of antimicrobial activity of bioactive molecules and plant extract.
- Study of anti-leishmanicidal activity of bio active molecules
- Study of invitro anti cancer and invitro antidiabetic activities
- Estimation of invitro anti oxidant activity using various models.
Hematology
- Semi auto analyzer for analysis of various biochemical parameters
- Hematology cell counter for analysis of hematological parameters and viable and non viable cancer cells
- Inverted microscope, including phase contrast
- Cooling Centrifuge
Analytical
- Spectroscopy - UV-Spectro, UV-Visible and FTIR.
- Chromatography – HPLC, UPLC and GC-HS (Waters and Agilent) – Underwent a instrument training at Apotex Pvt Ltd, Bangalore during (Sep16-Oct 2, 2010).
- Other instruments – Digital Melting Point apparatus (VEEGO, VMP-DS), Rotary Evaporator (Eyela), Biochemical Autoanalyser (Auccuacare-100), XRD analysis, pH meter, Flame Photometer
Computer skills
- Evaluation of Bio-medical data using specialized software like, MS Excel programs and Origin.
- Experienced with Internet applications for scientific research activities.
- Experienced in the use of MS office (MS Word, MS Excel, Power point) and other software packages such as Chemdraw, Basic Autocad etc.
- Chemdraw, Ultra Chemsketch.
Prizes/Medals/Awards/Distinctions
- Qualified in National level competitive examination of Graduate Aptitude Test in Engineering (GATE-2002, 2005 and 2008), particular in Pharmaceutical Sciences.
- Secured 1st Class in overall 2 years of M.Pharm, Jadavpur University, Kolkata, India.
- Secured 1st class in overall 4 years in B.Pharm College, Pallavan College of Pharmacy, Chennai, India.
Scholarship Received
- Awarded travel grant for attending The 1st Current Drug Development International Conference, May 6-8, 2010. Woraburi Resort and Spa, Phuket Thailand.
- Awarded Junior Research Fellowship by University Grants Commission (UGC) (2008 – Till date).
- Awarded Post Graduate Fellowship by the University Grants Commission (UGC), Ministry of Human Resource Development (HRD), New Delhi, India (2003-2005).
Membership in professional organizations
- Life member of The Indian Pharmaceutical Association (IPA), Mumbai-400 098, (Life/Ben/0245).
- Life member of The Tamil Nadu Pharmacy Council, Chennai (Certificate No 7712 A1).
Peer Reviewed Publications
1. An extensive in vitro evaluation of antioxidant activity of different fractions of Melothria maderaspatana ¬– Ashok Kumar Balaraman, Jagadish Singh, Sasmita Dash, Arup Naskar, Tapan Kumar Maity. Plant Foods for Human Nutrition, Springer Publication – In review.
2. Synthesis and Anticancer activity of some 1, 3, 4-Oxadiazole derivatives against Ehrlich ascites carcinoma bearing mice model- Jagadish Singh, Ashok Kumar B, Rajapandi R, Tritha Ghosh, Arijit Mondal, B C Maiti and T K. Maity. Pharmacologyonline 1 : 406-416 (2010).
3. Antihyperglycemic and hypolipidemic effects of Melothria maderaspatana and Coccinia indica in Streptozotocin induced diabetes in rats- Ashok Kumar Balaraman; Jagadish Singh; Sasmita Dash; Tapan K Maity Saudi Pharmaceutical Journal, (Elsevier publication). 18 :3, 173-178 (2010).
4. Immobilization of pancreatic porcine lipase in calcium and barium alginate comparative studies of their kinetic properties and screening the polymer for suitability- V.V. Prasanth, G. Parthasarathy, A. Puratchikody, Ashok Kumar Balaraman, B. Vinod, N.S. Chandrasheker and Sam T. Mathew. The Internet Journal of Pharmacology. 2009 Volume 6 Number 2
5. Evaluation of the analgesic and anti-inflammatory properties of methanol extract of Artanema sesamoides Benth roots in animal models - Malaya Gupta, U.K. Mazumder, V.Thamil selvan, L.Manikandan, Senthilkumar. G.P., R. Suresh, P. Gomathi, B. Ashok Kumar. Oriental Pharmacy and Experimental Medicine – Volume 8 Number 2, and June 2008.
Scientific Abstracts in seminars / conferences
o Antidiabetic potential of Melothria maderaspatana and its effect on lipid profile and liver glycogen content of STZ induced diabetic animals, Ashok Kumar Balaraman, Jagadish Singh, Sasmita Dash and Tapan Kumar Maity. Oral Presentation. The 1st Current Drug Development International Conference, May 6-8, 2010. Woraburi Resort and Spa, Phuket Thailand.
o Synthesis and anticancer activity of some 1, 3, 4-oxadiazole derivatives against Ehrlich ascites carcinoma bearing mice model- Ashok Kumar Balaraman, Jagadish Singh, Arijit Mondal, R.Rajapondi and Tapan Kumar Maity. Poster Presentation. The 1st Current Drug Development International Conference, May 6-8, 2010. Woraburi Resort and Spa, Phuket Thailand
o Anti diabetic and antibacterial efficacy of fruit extract of Terminalia Arjuna Roxb – Suresh Babu palanisamy, Ashok Kumar Balaraman and Balakrishnan Krishnamoorthi. Poster Presentation, The 1st Current Drug Development International Conference, May 6-8, 2010. Woraburi Resort and Spa, Phuket Thailand
o Enhancement of micromeritic properties of rifampicin by simple spherical crystallization technique’, GEA-NUS PPRL 10th Anniversary Commemorative Pharmaceutical Technology Conference. National University of Singapore. Singapore.
o Experimental and QSAR studies on antimicrobial activity of benzimidazole derivatives, GEA-NUS PPRL 10th Anniversary Commemorative Pharmaceutical Technology Conference. National University of Singapore. Singapore
o Assay for pBR322 DNA cleavage activity-Agarose gel electrophoresis in plumbagin, International conference at Bundelkhand University, Jhansi, (UP), India.
o Evaluations of Microbiological Studies on the ethanol extract of Terminalia arjuna Fruit, International conference at Dr. B.R.Ambedkar Centre for Biomedical Research, University of Delhi-110007.
o Isolation of Plumbagin, a 2 – Substituted Napthoquinone from plumbago Zeylanica Linn. And a comparative study on Lipid peroxidation of this Natural Derivative with some synthetic analogs, Indian Science Congress at Ahmadabad.
o Evaluation of antimicrobial activity and determination of ID50 values of Abrus precatorius seed extracts, accepted for the presentation in the National level ‘Pharma Innovations’ Symposium, Bharathidasan University, Trichy.
o The leishmanicidal activity of fruit of Terminalia arjuna, accepted for the presentation in the National level ‘Pharma Innovations’ Symposium, Bharathidasan University, Trichy.
Peer reviewer of following scientific journals

o Medicinal Chemistry Research (http ://www.springerlink.com/content/1054-2523/)
o Pharmaceutical Biology (http http://://www.informaworld.com/smpp/...ent=t713721640
Training Underwent
- Industrial training in Micro Labs Ltd. R.S No. 24/3&4 Thirubhuvanai, Pondicherry-605107. (Trained in sampling & Analysis of raw materials, production of Tablets & Capsule, Packaging and Quality Control Sections)
- Hospital and Clinical Training in Sri Ramachandra Hospital & research Institute, Porur, Chennai- 116
Volunteer Experience
Co-convener in conducting national level symposium on Exploring the Research Platform for Pharmaceutical Product and Process Development on 15th & 16th March 2008 at Anna University Tiruchirappalli.
Member of Local Organizing Committee in National Level Congress- 56TH IPC, Kolkata.
Extra Curricular Activities
- Preformed regularly as host / compeer in various college, university and social programs.
- Debates / Elocution (participated in “Talk Show” in Sun TV, the number one television channel in Tamilnadu.)
Other Attributes
Quick learner, Self-starter with smart presence of min, perseverance, Team skills, Flexibility, Good attitude, excellent presentation and communication skills
List of Referees :
Reference

Dr.A.Puratchikody, M.Pharm., Ph.D.,
Assistant Professor,
Department of Pharmaceutical Technology and
Director Academic courses,
Anna University Tiruchirappalli,
Tiruchirappalli -620 024, Tamil Nadu, India,
Mobile : +91-96266 090760431-2407995,
Email – puratchipharma AT gmail.com
Shankar Munusamy, M.S. (Pharm.), Ph.D.
Instructor,
Department of Physiology & Biophysics,
University of Mississippi Medical Center,
2500 North State Street,
Jackson, MS 39216,
Phone : 1-601-984-1802Mobile: 1-501-786-2769,
Email- shankarmunusamy AT gmail.com
The above furnished details are true the best of my knowledge.
Sincerely,
Ashok Kumar Balaraman.

[Guest]

R. ASHOK KUMAR
Email : ashokbiotechjmc AT gmail.com
Career Objective
I would like to work for an organization where I can pursue my goal of building a good career with an intention of effectively being able to contribute my best to the organization. I believe in growing with the organization.
Education Qualification :
M.Sc., (Hons) in Biotechnology with 70% from
Jamal Mohamed College,Tiruchirappalli
(Bharathidhasan University 2009-2011)
B.Sc., in Biotechnology with 72% from
Islamiah College, Vaniyambadi
(Thiruvalluvar University 2006-2009)
H.S.C with 67% from
T.N.A.P.G Higher Secondary School, Tiruvannamalai (2004-2006)
S.S.L.C with 85% from
Hindu Higher Secondary School, Ambur
(2002-2003)
Proficiency in Techniques :
Biochemistry :
TLC, ion-exchange, column Chromatography Techniques, Electrophoresis (SDS PAGE, Agarose Gel), Estimation of DNA, Protein (UV spectrophotometer and Colorimetry).

Molecular Biology and Immunological techniques :

Blood Grouping, Ag-Ab Interaction, Blood counting, Western Blotting, Polymerase Chain Reaction, Double Immune Diffusion, ELISA Technique etc...
Plant Tissue Culture :

Plant Tissue culture – sterilization, Media preparation and Hormones.
Micro propagation, Callus Induction, Cell suspension Cultures, Anther culture, Pollen culture, Protoplast culture.
Microbial techniques :

Plating, Pure culture techniques Staining (Simple, Gram’s, Negative, Spore, Acid-Fast), Isolation of DNA from various organisms, plants, and animal.
Bioinformatics software’s :
Hex,
Argus lab,
Homology Modeling- Swiss-PDB viewer (SPDBV),
Discover studio 2.5,
Auto dock,
Project Details :
Bioinformatics
COMPITUTIONAL BIOLOGY AND CHEMISTRY :
Title : A computational study on the binding specificity of h1n1 to its receptor
Conclusion :
Structural aspects
Here I mutated the Amino acids groups from the Pdb (Protein Data Base) files and I prepared a Drug likeMolecules (Receptors form RCSB server + sample drug from Drug Bank server) against the H1N1 Neuraminidase Receptor Enzymes and how that Drug molecules will go and bind with receptor enzyme and controlling the Replication of H1N1 Neuraminidase based on the binding specificity
Software skills
o Diploma in Computer Application
o Diploma in Typewriting (English)
o Operating Systems : Windows XP, Linux (Cent OS)
o Participated various seminars
Area of Interest
o Research and Development
o Quality Assurance (or) production manager
o Clinical Research (or) field related jobs

[Guest]

VAIBHAV GAJANAN KULKARNI
E-Mail : vahbiav08 AT yahoo.in

Desired to join an organization where my experience, educational and functional talents will make me innovative, resourceful and flexible so as to contribute to personal, professional and organizational growth, through the quality oriented work.
Name of the exam University/ Board College Year Percentage
Diploma in Regulatory Affairs GIRA Pune (Distance)
Global Institute of Regulatory Affairs, Pune 2011 Result waited.
B. Pharm Amravati University. S.G.S.P.S. Institute of Pharmacy, Akola 2010 70.40%
D. Pharm
MSBTE Board Geetadevi Khandelwal Institute of Pharmacy, Akola. 2007 79.20%
H.S.C. Amravati University. Jagruti Junior college, Akola 2005 64.81%
S.S.C. Maharashtra State Education Board. Bharat Vidyalaya, Akola, 2003 72.32%
Name of organization Designation Experience
“ZIM Laboratories Limited”,
Kalmeshwar, Nagpur

( WHO, NQAQSR, ISO certified)
IPQA Chemist
From July 2010 till present.

- In process checks and sampling at granulation, tablet, capsule, pellet, dry syrup, primary and secondary packaging departments and there documentation,
- Calibration of instruments in production area & its documentation,
- Documentation related to QA eg : Change control, Deviation, Pressure differential, NCR, Temp & RH, Internal correspondence, RM dispensing, Log books maintenance etc
- Execute batch card review, water system maintenance & cleaning sampling.
- Participated in preparation of WHO audit and faced the same.
- Knowledge of ICH,CTD & Stability guidelines.

Topic name : To compare and distinguish various formats of dossier accepted in different parts of the world.
Key points : CTD, ACTD, Indian Regulatory requirements, ICH etc.
.
- A poster presentation on “Need for Pharmacovigilance” in International seminar on “Recent advancement in the Pharmacological science” held at Pravara college of Pharmacy, Loni.
- A poster presentation on “Nanoparticles : Drug Delivery System in TB” in National Level Symposium “ABHIGYAN-2” held at COETA, Akola.
- A poster presentation on “Modified release dosage form as a drug delivery system” in National Pharmacy Week held at Vidyabharti college of Pharmacy, Amravati.
- Ms Office, UNIX,
- Coral Draw & Page maker software,
- Worked as an Editor of college magazine “MORPHEUS – In Quest Of Dreams” in 2009-10.
- Won various prizes in speech, debate, & chess in intercollegiate competitions.
- Active participation in annual gathering & National Social Service activities.
- Elementary Drawing Exam Passed.

[Guest]

CHETNA JATRAN
Email- drachetna AT gmail.com

OBJECTIVE
To work for challenging assignments with a clear focus to achieve excellence in the line of work and prove myself as an undistinguished and leading part of a professional growth oriented Organization through deploying my skills and abilities.
JOB DESCRIPTION AND AREA OF INTEREST
Drug regulatory affairs / Regulatory Officer
FORMAL EDUCATION
- M. Pharm.(2009-11) pursuing, with specialization in Pharmaceutics (Drug Regulatory Affairs) from Department of Pharmaceutical Sciences ( Maharshi Dayanand University, Rohtak)
- B. Pharm. (2005-09) from Department of Pharmaceutical Sciences (Maharshi Dayanand University, Rohtak).
- Senior Secondary (2004) from Govt. Model Sr. Sec. School, Sector-19C, Chandigarh. (Central Board of Secondary Education)
- Secondary (2002) from Govt. Model Sr. Sec. School, Sector-19C, Chandigarh (Central Board of Secondary Education)
ACADEMIC RECORDS
M.PHARM
1ST SEM. 71.66%
2ND SEM.
3rd SEM. 78%
70%
B.PHARM
1ST YEAR 66.62%
2ND YEAR 67.60%
3RD YEAR 69.07%
4TH YEAR 65.12%
Aggregate score 67.13%
12th 69%
10th 79.4%
M. PHARM. DISSERTATION WORK AND SUPERVISOR
Dissertation work : “Prescription Drugs Labeling – Significance and Regulatory Requirements”
Dissertation contains exhaustive research on Regulatory Requirements for Prescription Drugs Labeling in various countries (USA, CANADA, INDIA, SOUTH-AFRICA), and required documentation for labeling for an ANDA submission as per various International Drug Regulatory Bodies (especially USFDA).
- Supervisor : Prof.(Dr.) Harish Dureja (M.D.University, Rohtak)
- Co-supervisor : Mr. Anirudh Vashisth (Jubilant Life Sciences Ltd. Noida)
COMPUTER PROFICIENCY
MS-Windows 7, MS office 2003/2007 (Word, Power Point, Excel), DTP, Internet Searching
ACHEIVEMENTS
- Qualified in GATE- 2009 Examination conducted by Indian Institute of Technology, Roorkee, India.
- Presented on topics “ICH- An Introduction”
“Orphan Drugs- An Overview”, during academics and on topics
“Genotoxic Impurities - A Regulatory perspective”, and
“Scale-up and Post approval Changes in USA and Europe” during Training in Jubilant Life Sciences Ltd.
- Participated in one day Seminar on “Common Technical Document” held at NIPER in 2011.
- Participated as delegate and presented a poster entitled “Environment Protection-International Concerns” in National Seminar on “Environment Challenges-Sustainable Development” during March 2010.
- Presented a poster during National Pharmacy week in 2008
INDUSTRIAL EXPERIENCE
- 8 months experience as Trainee in Regulatory Department (USA) at Jubilant Life Sciences Ltd., Noida (U. P.). Basic knowledge regarding Review of documents :
- Specifications (API, Excipients, Drug Product)
- Drug Master Files (DMF)
- COA’s (API, Excipients, Drug Product)
- Labels, Pack-inserts
- Formula Clearance
- Validation Reports (Method Validation and Process Validation)
- Product Development Reports
- Stability sheets
GUIDELINES STUDIED
- ICH guidelines (Quality), USFDA guidelines

[Guest]

Kirpa Patel
Email- kirpapatel7 AT gmail.com
CAREER OBJECTIVE :
To work in a challenging atmosphere that provides me ample opportunity for learning and growth and to carve a niche in whatever I undertake.
AREAS OF INTEREST :
Health Economics and Outcome Research, Market Research Analysis, Clinical Research, Clinical Data Management, Pharmacovigilance, Regulatory affairs, Medical Writing, Intellectual Property Right.
EDUCATIONAL QUALIFICATION :
S.N Description Board/University Year Percentage/CGPA
1 M. Pharm NIPER, Mohali 2009 8.24 CGPA
2 GATE IIT Kharagpur 2007 76.70 percentile
3 B. Pharm. Gujarat University[L M College of Pharmacy] 2007 63.00%
4 HSC Gujarat Board 2003 48.92%
5 SSC Gujarat Board 2001 84.29%
PROJECTS :
M. Pharm Research Project : “To assess medication usage behavior and prescription drug knowledge in outpatient followed by patient counseling to improve patient compliance and therapeutic outcome.”
Summer Training Project : “To evaluate inventory control and value added customer services provided” at The Medicine Shoppe outlets, Mumbai (5 Weeks), June 2008.
MAJOR COURSES STUDIED UNDER M. PHARM CURRICULUM :
- Clinical and Applied Therapeutics
- Biopharmaceutics and Pharmacokinetics
- Biostatistics
- EBM and Critical Appraisal
TECHNICAL SKILLS
- Good understanding on concepts of Epidemiology study of drugs
- Proficient understanding of ICH & GCP guidelines
- Good understanding of the global pharmaceutical industry and knowledge of various therapeutic areas
- Proficient in peer reviewing articles, research papers
- Excellent skills for data interpretation and analysis
- Proficiency in scientific documentation
- Good in reviewing drug related errors from Prescription, patient details and case reports
- Excellent communication skill and projecting details scientifically
WORK EXPERIENCE / INDUSTRIAL TRAINING :
- Clinical Exposure : More than One and half year experience in different clinical settings. Worked as “trainee clinical pharmacist” on disease management, appropriate selection of therapy and drug-related problems. Underwent 800 hrs of training at 4 different clinical wards at Medicine, Pediatrics, General Surgery ward of Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh; Cardiac & Multispecialty wards in Fortis Hospital, Mohali.
- Trained at the Medicine Information Centre, NIPER on day-to-day operations.
- 3 months training at Relish Pharmaceuticals, Kalol, Gujarat.
WORK EXPERIENCE
-
As a Trainee for 6 months :
F&D Department of Dishman Pharmaceuticals and Chemicals Limited-
- Development, Optimization and taking trials for establishment of product.
- Preparation of established products on bulk scale for charging products into stability chamber for studying Physical parameters
- Handled trial Projects of different products like Solution [CHG 0.05% Antiseptic Solution], Gel [CHG Hand Wash Gel] , Face Wash Foam [Salicylic Acid Antiacne Face wash Foam] , Scrub [CHG Hand Scrub] , Mouth Wash [Hexetidine Mouth Wash], and Wipes [Student Wet Wipes, Feminine Wet Wipes, Baby Care Wet Wipes] Formulations.
- Preparation of dossier, labels and documents related to submission to regulatory body for initial approval basis and for tracking product development phase.
- Dossier compilation
- Taking follow up of the earlier and current reports from Analysis and Microbiology department from physical, chemical parameters stability and microbial growth in the products point of view and to implement appropriate steps as necessary for enhancing product stability
CONFERENCES/WORKSHOPS :
- Volunteer in “Symposium on Clinical Research and Training” held at NIPER in Feb. 2009
- Volunteer in 40th Annual conference of the Indian Pharmacological Society (IPS) on “Changing Trends in Drug Discovery and Development” held at NIPER in Nov. 2007
- Participated in “Awareness of Pharmacovigilance” workshop organized by Ranbaxy Laboratories Limited at NIPER in Nov. 2007
SEMINARS PRESENTED DURING M. PHARM COURSE :
- Therapeutic, EBM, Journal club & hospital case presentations
- Seminar on MODEL COMMUNITY PHARMACY and CLINICAL TRIAL PROCESS
- Introductory presentation on products like WET WIPES [FEMININE, BABY, MOSQUITO REPELLANT, etc] to Management team and Clients of Company
CERTIFICATE COURSES COMPLETED
- ‘General Course on Intellectual Property’,WIPO WORLDWIDE ACADEMY
COMPUTER PROFICIENCY :
- Proficient in Windows and application software : Windows XP, MS Office, EndNote
- Statistical Software : Sigmastat
- Data retrieval from various internet portals like Science direct, Pubmed, Highwire press, google scholar etc
- Databases like Micromedex, Cochrane library, TRIP, MEDLINE, Clinical Reference Library, Martindale, PDR, Clinical pharmacology etc
EXTRA CURRICULAR ACTIVITIES :
- Cricket, carom Champion in B.Pharm and M.Pharm
- Participated in Kabaddi and Khokho in School.

[Guest]

Dear Sir/ Madam my self Ritu Sharma i have completed M pharma (Pharmaceutical Chemistry) and looking for suitable opening in QA, If any vacancy,

[Guest]

CURRICULUM VITAE
VIJAY THAKUR
vijay773 AT gmail.com

OBJECTIVE : I wish to achieve excellence in the field of my work and I believe my sincere efforts will be definitely rewarded.
EDUCATION :
Examination
Discipline/
Specialization School/college Board/
University Year of Passing %

B.Tech
Electronics & Communication Engineering Green Hills Engineering college H.P.U
SHIMLA
2008 74.3%
12th
Science + Math Stream National Insitute Of Open School University N.I.O.S
2004 72.2%
10th
Matric Shishu Shiksha Niketan Totu Shimla H.P BOARD DHARAMSHALA 2000 57.8%
WORK EXPERIENCE :
Presently working (Since July, 2008) with “Recorders & Medicare Systems Pvt. Ltd.” as a Quality Control Engineer :- 2.8 YEAR experience.
SKILLS PROFICIENT IN :

1 Digital electronics
2 Networking
3 Analog & Digital Communication
SOFTWARE SKILLS
1 C,C++ (Language basic knowledge).
2 Worked on windows operating system.
3 Know how of MS office.

COURSES AND TRANING :
1 Switch Room Training From B.S.N.L (4 weeks)
2 Industrial Training From B.S.N.L(6 weeks)
3 C/C++ Certificate Course from Shimla (4 weeks)
4 persuing MBA
PROJECT :
1 Moving Display Message.
2 Study of the C-ARM machine.
SUBJECTS OF INTREST :
1 Playing Cricket
2 Listening music
3 Trekking
STRENGTH :
1 Honesty
2 Confidence
3 Hard Worker
4 Quick Learner
5 Positive Attitude

[Guest]

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