Resume / CV : Pharma Regulatory Affairs Officer

[Urmilesh]

URMILESH JHA
E-mail : jha_urm AT rediffmail.com

Past record : (including academic education):
o Lectuer, TIT-College of Pharmacy, Anand Nagar, Bhopal (Feb 2009 to uptill now).
Responsibility : taking classes for M.Pharm student Biotechnoly and molecular biology, Pharmacology and clinical pharmacy for undergraduate classes.
o Lecturer & HOD Dept. of pharmacology, Parul Institute of Pharmacy, Limda, Talk-Waghodia, Dist-Vadodara.(Feb2007 –Feb2009).
Responsibility : taking lectures for final year and third year for subject clinical pharmacy and pharmacology and member secretary of Institutional Ethical committee cum Animal house in-charge of the institute.

Education :
o M. Pharm (Pharmacology), from Krupanidhi college of Pharmacy,5-Sarjapur Road, Koramangala , Bangalore (Karnataka) affiliated to Rajiv Gandhi University of Health Sciences, Bangalore, Karnataka With 73.45 %. Aggregate marks (2005-2007).
o B.Pharm. from Krupanidhi College of Pharmacy B,lore affiliated to Rajiv Gandhi University of health and sciences with 63.96% (2000-2005).
o D.Pharm. Govt pharmacy school Patna with 67.00%.( 2000)
o Undergone 750 hour’s hospital training in Nalanda, Medical College Patna, Bihar.
o S.S.L.C Bihar intermediate education council, Patna Bihar with 52.33%marks. (1992).
o H.S.L.C Bihar school education board, Patna with 48.33% marks (1989).
o Guided five B.Pharm.students for their project work in Rajiv Gandhi Technical University, Bhopal (M.P.)
o Doing Master of Hospital Administration (M.H.A.) from ICFAI University, Hyderabad. India. Enrollment no. 6015050914562.

Scholarship, bursaries and Fellowships awarded :
o Qualified GATE 2000 with 87.97 percentile
o Got M.H.R.D.Scholarship for persuing post graduate course.

DISSERTATION : (M.Pharma Project)
o Evaluation of fertility inducing effect of Coccinia cordifolia in rat.

Technical skills :
Drug evaluation and screening activities :
o Knowledge of maintenance of animal house under CPCSEA guideline.
o Well versed in Jugular vein cannulation and many animal screening techniques of drug evaluation.
o Well known to biostatical parameters (ANOVA, Student's t-test, chi-square test).
o Experience of rat brain mapping using stereo tactic apparatus, handling of Langendorff’s apparatus.
o Well versed in Bioavailability & Bioequivalence study.

Drug development processes :
o Well versed in drug development processes (Pre-clinical and Clinical trial, IND and NDA, ICMR, ICH guidelines, GCP requirement, Protocol writing and Informed consent).
o Knowledge of notice to Applicant for dossier writing.

Experience in Microbiological techniques :
o Exposure to micro activities such as Micro sampling, Inoculation sterility, and contamination checks, Micronucleus nucleus test,

Others Skills :
o Basic knowledge of computer

Scientific Publications :
o Study the effect of coccinia cordifolia on the endometriosis in rat Indian journal of pharmacology (Under communication )
o Fertility inducing effect of aerial parts of Coccinia cordifolia L. in rats J Ethnopharmacol. 2009 Oct24

Congresses, Conferences and Workshops :
o Attended 11th convention of Association of Pharmaceutical Teachers of India in 2006 held at Bangalore.
o Attended 59th Indian Pharmaceutical Congress 2007 held at Varanasi. Paper presented in poster session of 59th IPC Varanasi. Evaluation of Fertility Inducing Effect of Coccinia Cordifolia in Rat.
o Attended GUJCOST & GLPL sponsored national Symposium on “Nanoparticle in drug delivery “ on 5th and 6th july 2008
o Attended GUJCOST sponsored seminar on “New avenues in preclinical and clinical studies” on 28 Th Sep 2008.
o Attended symposium on translational research n cardiovascular medicine : from bench to bedside vice versa organized by M.S. University Baroda & IACS, Canada. on 11th Dec 2008

[anil_pharma07]

Curriculum Vitae:
Anil Kumar
anil_pharma07 AT yahoo.co.in, anil_jaiswal AT jcbl.com

OBJECTIVE :-
Challenging career in Formulation Research and Development where I can enhance my knowledge and skill to the best of my ability and contribute towards the growth of organization.

PROFESSIONAL PROFILE :-
Work with ACME formulation (P) Ltd. As a officer in “Formulation Research and Development” since Feb 2010 till today.

JOB PROFILE :
1. Development of various solid dosage forms for regulated, Semi regulated and ROW markets, developing dosage form are uncoated, coated tablets and capsules.
2. Job involve literature search, patent search and evaluation, evaluation of suitable excipients for formulation, evaluation of packing materials and evaluation of suitable manufacturing process, accordingly take trial batches.
a) Literature survey
b) Pre-formulation study
c) Incompatibility study
d) Innovator sample characterization
3. Checking in process parameter during product development.
4. Create, conduct and evaluate the stability program as per ICH guidelines supporting the product development process.
5. Preparation of technology transfer documents.
6. Trouble shooting of different product in production area.
7. Also involved in Pre formulation of existing products to improve quality and cost reduction.
8. Preparation of product development report, Master formula record, Bill of materials, stability protocol, tentative finished product specification.
9. Taken various scale up batches in production plant.
10. Preparation of strategies for Formulation Development.
11. Sustained release drug delivery system : Matrix based ER tablets & Capsules.
12. Controlled release drug delivery system : Enteric coated tablets & Capsules.
13. Immediate release drug delivery system.
14. Taste masking formulation : Tablets
15. Monitoring the stability batches of In-house.

Knowledge of Guidelines :
- Well verse in generic formulation development of solid oral dosage form.
- Knowledge of ICH guidelines.
- Understanding of dissolution profile.
- Knowledge of pharmaceutical excipients.

INSTRUMENTS HANDLED :
Rapid mixer granulator, Multimill, Fluidized bed dryer, Tablets compression machine, Octagonal blender, Vibratory sifter, Ultra centrifugation apparatus, IR balance, UV spectroscopy and disintegration apparatus.

Project Work : Formulation and development of Ethosomal drug delivery of Anti-fungal drug (Econazole nitrate).

COMPUTER SKILLS :-
- MS Office (Word, PowerPoint, Excel)
- Information retrieval using internet.
- Familiar with various scientific software

TECHNICAL EDUCATION :-
- Master of Pharmacy (Pharmaceutics) from Uttar Pradesh Technical University, Lucknow in 2010.
- Bachelor of Pharmaceutical Sciences from Uttar Pradesh Technical University, Lucknow in 2007.
Registered as a Chemist in Pharmacy Council of Uttar Pradesh.

ACHIEVEMENTS :
- Qualified GATE in 2006 (78.8 percentile) and in 2007 (96.6 percentile) conducted by IIT Kanpur and IIT Kharagpur.
- Participated in quiz competition & cultural programs in institute.

INDUSTRIAL VISIT :-
- Panacea Biotech.
- Torrent Pharmaceutical Ltd.
- Dr. Morpen Laboratories.

STRENGTH :
- I can think at micro level as well as at macro level.
- Comprehensive problem solving abilities, ability to deal with people diplomatically, willingness to prove team facilitator with hard work, sportsman spirit, and good practical skills.
- Good team player, flair for learning, positive attitude, adaptability and flexibility, self motivated, sharp analytical abilities, planning priorities and meeting deadlines.

[Guest]

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