RESUME

** *** ********** ***.+Pharma industral Mfg&Research exp.of generic drugs (USA), Appoved by FDCA,Gujarat in Parentral section

Industry Focus: Research, Manufacturing & Production Job Title: 25 yrs Regulatory exp.+Pharma industral Mfg&Research exp.of generic drugs (USA)

Experience: 21+ Years Looking For: Any Position Type

Visa Status: Non U.S. Citizen Salary: $85000 - $100000

Education Level: Post Graduate Degree

RESUME________________________________

OBJECTIVE: Seeking a suitable position , Where a proven need of Success and knowledge will be utilized and further developed.

EDUCATION: M. Pharm with first class, L.M. collage of Pharmacy. Ahmedabad

(Gujarat University)

ACADEMIC EXPERIENCE:

1 Internship: (Period 1st September ’81 to 1st December 1981 after passing graduation B.

Pharmacy)

Worked as an apprentice for 3 months and spent in testing of drugs in quality

control Department of Cadila Laboratories, Ahmedabad.

2 Thesis A thesis submission to Gujarat university in partial fulfillment of the

(Dissertation) requirement for the degree of master of Pharmacy in pharmaceutical

chemistry =(Topic = Synthesis of some N,N’- disubsituted thieno (2,3)

pyrimidine – 2,4 – diamines as potential anti malarial agents (totally new

drugs synthesized and proved by practical findings, such as IR spectra, UV

Spectra, Mass spectra , Carbon – Hydrogen percentage analysis)

INDUSTRIAL EXPERIENCE :

3 McGaw- Production Assistant (period from 01/08/1983 to 26/05/1984)

Ravindra

Laboratories Responsible for the work related with production of large volume

(Arvind parenterals formulations which was designed in collaboration with the

Group). McGaw, U.S.A.

Ahmedabad

Established and systematized facilities to take the productive work

from operators for company’s production targets.

Co-coordinated with trouble shooting of any manufacturing

instruments or machineries with maintenance depts. & QC departments.

Maintained all records of batch manufacturing and processing, such as,

mixing, filling, indenting & requisition of Raw Materials, Sterilization,

Packing & Labeling, Rejection records thereof and stock keeping of finished

Goods, etc.

Supervised the follow up of regulations i.e. Good manufacturing practice and

standard operating procedures.

4 Ivee Injectaa Production Chemist (Period 15/06/1984 to 08/11/1985)

pvt. Ltd.

Implemented the work regarding production activites of large volumeJunagadh

Parenterals formulations.

Working pattern as described in point no. (3) so as to achieve desired

production targets.

Received as approval to manufacture parenterals products as a

“Technical Person” in parenterals section (mfg) vide order of director

of Food & Drugs Control Administration, Gandhinagar, vide no:

TP/Ivee/246/B, dated 04/12/1985.

5 Cadila Plant Chemist: (Period 16/12/1985 to 23/05/1986)

Laboratories

Pvt. Ltd., Responsible for the work related with the manufacturing of small volume

Ahmedabad Parenterals.

Established and systematized facilities to take productive work from

operators for company’s benefit.

Maintained all records of batch processing such as planning of batch mixing,

filling, etc.

Maintenance of aseptic area and preparation of the area for the production

activites.

Planning of the production activities so as to achieve optimum production

targets for the small volume parenterals manufacturing for exports and

indigenous markets

Supervised follow up regulations i.e. Good Manufacturing Practice and

Standard Operating Procedures.

6 Food & Drugs Drug Inspector (Gazetted post in Gujarat Govt. Services in Class-2) Control (Period 26/05/1986 to 16/06/1999)

Administration,

Gujarat State, Responsible for inspection activities of drugs sales premises in the area, Gandhinagar allotted from time to time within the specified area.

Inspecting all the new application for sale of drugs to procedure the license

from FDA, Gujarat State in the Jurisdiction, specified in the duties.

Investigating all the complaints, regarding the drugs & Cosmetics within the

specified Jurisdiction.

Implementation of Drugs & Cosmetics Act 1940 & rules made there under

in Indian territories (Gujarat State only) & Sampling of drugs & Cosmetics

etc.

Investigation of drugs & Cosmetics if come across regarding the breach of

the act & rules. (Especially not of standard drugs and spurious drugs or unlicensed drugs dealers etc.)

Implementation of work allotted from collector office & election officer during election duties.

Undertaken the administrative training from Sardar Patel Institute of public Administration, Ahmedabad from time to time allotted from Gujarat Govt.

Promoted as a Senior Drugs Inspector vide Commissioner’s order FDA. Gujarat State, Gandhinagar vide order no: Badhat/1099/35508-625/a, dated 17/06/1999.

7 Senior Drugs (Promoted from the post of Drugs Inspector (Gazetted post in Gujarat Govt. Inspector Services Class II ) (Period from 17/06/1999)

Responsible for Inspection activities of drugs manufacturing premises in the area, allotted from time to time within the specified area.

Inspecting all the new applications for manufacture of drugs (Allopathic as well as Ayurvedic) to procedure the license from Food & Drugs Control Administration, Gujarat State, Gandhinagar in the specified Jurisdiction.

Investigating all the complaints, regarding mfg of the drugs & Cosmetics, within the specified Jurisdiction.

Implementing of Drugs & Cosmetics Act 1940 & rules made there under in Gujarat State, (India) & Sampling of drugs & Cosmetics etc.

Inspecting all the manufacturing units in the specified Jurisdiction with a view to implement the GMP regulations, (states) as well as WHO GMP rules and their guidelines. Furthermore inspecting the quality control Laboratories, checking of GLP’s, methods of Validitation of equipments & compliances thereof.

Investigation & prosecution regarding the breach of Drugs & Cosmetics Act 1940 & allied laws related with Drugs & Cosmetics & launching the cases in honorable court in regards to not of standard Quality drugs & Cosmetics as well as spurious drugs & Cosmetics (Allopathic as well as Ayurvedic drugs)

Implemented of work, allotted from collector’s office & Election officer, during election time from time to time.

Implemented the training class for “Karmayogi”, as allotted from Gujarat Administration Dept. Gujarat (serving the similar Govt. Organization FDA, Gujarat State as a “Senior Drugs Inspector” from the period 17/06/1999 to till today and now due for the promotion of “Assistant Commissioner, class-1 in Govt. Services, under regular promotion on seniority basis.

8 Experience in U.S.A.

Worked in Formulation R & D Dept. in a company, Manufacturing the Drugs Formulations (Tablets & Capsules ) leased at New Jersey U.S.A., having a annual turnover of $200 million& above.

The firm is having an expansion projections in R & D sector in few months . At presently, R & D products are based on the research which involves the total new generic formulations, based on similar brand products, running in U.S.A. markets.

Research involves stability studies, Compatibility with other ingredients, evaluation of new formula, which is safe, efficacious and good in Quality as per the norms of the U.S.A. guidelines.

Worked from around april-06 till to 01/07/08. as a Scietist in F R&D Lab..

9. Experience in Rajkot in academic field.

Worked as an“ Assistant Professor” in one Pharmacy college in Rajkot for

the period 16-12-2009 to 31-1-2009.

10)Total Experience: 25 year

11) Relevent experience: Approved in all formulations in India, As I have served as a inspecting authorities in Sales and can be furnished,while personal interview.

12) 49 years completed.

13) CurrentCTC: Not employed by any firm.can be resumed any firm in short time.

Last Salary drawn in:

India : 4 Lacs at present scale.

USA Emoluments: 40,000 to 50,000 $ with all company benefits.

Expected CTC: As prevelent in Industtries +Perks if any.

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