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Drug Regulatory Affairs Resume Sample, Experience : 2 years

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Name of the Candidate:[Private]
Name of the Post Applied:Drug Regulatory Affairs
Job related skills / software:QA, IPQA, Regulatory Document Review, Calibration of IPQC equipment’s and instruments as per schedule, Perform Line clearance activity at various stage of manufacturing and packing.
Category:Medical
Sub Category:Drug Regulatory Affairs Executive
Years of Experience:2 years
State:Maharashtra
Gender:Male
Salary Expected per Month(Rs):30,000 to 40,000
Highest Qualification attained:M.Pharm. : Master of Pharmacy
Major / Specialization:Pharmaceutical Chemistry
Email Id:[Private]
 
Are you looking for job now?:Yes
Can the recruiter contact you?:Yes
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Curriculum Vitae  :
Mr. AMOL SHIVAJI BIDGAR
Mobile No : +91-8275020574
Email Id : amol.bidgar91 AT gmail.com
Permanent Address :
A/p kanadgaon Tal-chandwad,
Dist-Nasik, Pin -423104.

Personal Details :
Date of Birth :23 March 1991
Sex  : Male
Religion  : Hindu
Nationality  : Indian
Marital Status  : Married

Language Known :
English, Marathi, Hindi

Personal Traits :
** Problem solving skill
** Practical and rational thinking
** Self-confident and strong determination
** Dedicated towards goal
** Good communication.

Objectives :
An enthusiastic, creative and self-motivated candidate having strong educational and pharmaceutical and formulation based background, regardless giving the best of knowledge and skillful work to enrich valuable targeted goal of an organization.

Quality Assurance  :
Duration- August 2015 to present
“Mylan Laboratories Limited, Aurangabad”(Accredited with US-FDA, MHRA-UK, WHO-GENEVA, TGA-AUSTRALIA Regulatory agencies)
One month practical training in MAXHEAL PHARMACEUTICALS, Satpur Nasik.

Job Responsibilities :
** Supervision of each manufacturing activity and ensuring that activities in manufacturing area are strictly adhere to cGMP standards.
** Calibration of IPQC equipment’s and instruments as per schedule.
** Perform Line clearance activity at various stage of manufacturing and packing.
** Perform in-process checks at various stages of production as per SOPs & BPCR and online recording of it.
** Review all the cGMP documents for manufacturing activities & release the product for next stage.
** Performing sampling at various stages such as in process, finished product, stability, Cleaning (Swab) & Hold time study.
** Involved in monitoring of validation, exhibit and scale up batches.
** Also, perform sampling of validation, exhibit and scale up batches
** Ensure cGMP & Safety compliance & Reporting of Incidences, deviations.
** Train subordinate staff and new employees.
** Involved in GDP implementation in production and also train new subordinates regarding GDP.

Educational Qualification :
** M.


Pharmacy Govt. college of pharmacy Aurangabad 2015 66.19 GPAT, NIPER AICTE 2013 Qualified
** B. Pharmacy M.G. V`S pharmacy college Nasik. 2013 60.58
** D. Pharmacy SNJB`S SDFL pharmacy college Chandwad, Nasik. 2010 75.80
** HSC Arts Science & commerce college Manmad, Nasik 2008 60.83
** SSC P.A.M.V. Kanadgaon , Nasik 2006 70.66

Research Project :
Carried out project work on “GQSAR, Synthesis & Biological screening of some novel xanthone derivatives as an anticancer agent”

Audit Faced :
Successfully faced USFDA Audit, WHO Audit, MHRA Audit and various internal quality audits.

Declaration :
I hereby declare that the information furnished above is true to the best of my knowledge.

Date :
Place :

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