BrightOwl Loader Loading

Summary

Career objective acquire a challenging position in a leading Entrepreneurship , where gained experience and knowledge could be applied for the growth of individual and the environment itself. abilities • strong Communication Skills and interpersonal motivational management skills • analytical thinking & team leading capabilities. • self confident. • working independently • i’ll be a good initiator with multi tasking & Time Management skills • organised several competition events • Operations experience, running large teams. • Energy/hunger for growth • intellectual horsepower • global exposure • commercial savvy • excellent communication & executive presence to connect at client vs company level • ability to influence multiple internal stakeholders • ability to built deep client partnerships • ability to lead & build strong teams • strong quantitative and Analytical Skills skill sets • preparing • batch Manufacturing records(bmr’s) and batch production records(bpr’s) • protocols and reports for validation and Qualification section • Risk Assessment protocols and reports using FMEA and HACCP techniques • Cleaning Validation protocols and reports including matrix • annual product review reports • stability studies as per ICH guidelines, patent review

Experiences

Current Experience

  • PROS Jr Associate


    Since February 2015
    include the following. other duties may be assigned. • provide advanced paper and electronic publishing services including document preparation, legacy conversion, scanning, rendering, bookmarking, hyperlinking, compilation, table of contents creation, volumation, pagination, and formatting of complex submissions. prepare templates and set up submissions. • perform Quality Assurance of published output for completeness and correctness in formatting and navigation. • perform advanced Document Management tasks including file transfer, storage, tracking, and archival. • maintain familiarity with current global regulatory submission standards. contribute to departmental interpretations and best practices. • maintain familiarity with and contribute to departmental standard operating procedures and work instructions. • provide project team Leadership and manage publishing tasks. initiate, plan, execute, control, and close assigned projects. articulate procedures and solutions to multi-level team under time pressures imposed by business-critical deadlines. • formulate and deliver Presentations and workshops. provide assistance to other departments including Consulting services, Technical Support, Product management, Sales, and Regulatory Affairs as needed. attend conferences and educate internal team on industry news. • manage objective setting, Career advancement activities, and skill development for direct reports and ensure appropriate performance assessments. • estimate and report assigned project revenue. Include the following. Other duties may be assigned. • Provide advanced paper and electronic publishing services including document preparation, legacy conversion, scanning, rendering, bookmarking, hyperlinking, compilation, table of contents creation, volumation, pagination, and formatting of complex submissions. Prepare templates and set up submissions. • Perform quality assurance of published output for completeness and correctness in formatting and navigation. • Perform advanced document management tasks including file transfer, storage, tracking, and archival. • Maintain familiarity with current global regulatory submission standards. Contribute to departmental interpretations and best practices. • Maintain familiarity with and contribute to departmental standard operating procedures and work instructions. • Provide project team leadership and manage publishing tasks. Initiate, plan, execute, control, and close assigned projects. Articulate procedures and solutions to multi-level team under time pressures imposed by business-critical deadlines. • Formulate and deliver presentations and workshops. Provide assistance to other departments including Consulting Services, Technical Support, Product Management, Sales, and Regulatory Affairs as needed. Attend conferences and educate internal team on industry news. • Manage objective setting, career advancement activities, and skill development for direct reports and ensure appropriate performance assessments. • Estimate and report assigned project revenue.

Past Experience

  • Associate

    April 2014 --- February 2015
    i was handling mrt for eudra and xevmpd project

  • student m.pharmacy

    December 2011 --- December 2013

  • Trying to crack

    January 2013 --- January 2013

  • Project Trainee

    January 2013 --- January 2013
    i, sudharsan completed my m.Pharmacy in Pharmaceutical management and Regulatory Affairs . i gone through with my interested subjects in project covering the both the management & regulatory aspects Mergers & Acquisitions of pharma companies and eCTD filing for dossier submission, prior approval supplement,and annual reportable changes. cbe30 , deficiencies in ctd

  • TRIANEE PRODUCTION OFFICER

    December 2010 --- August 2011
    productional activities , granulation compression sieving milling visual inspection online bmr maintenance etc...

Knowledge

LinkedIn Assessment :
Regulatory affairsPharmaceutical IndustrySOPGMPPharmacovigilanceRegulatory submissionsValidationHPLCPharmaceuticsGood Laboratory Practice (GLP)ANDAClinical trialseCTD

Education

  • B.PHARMACY in Pharmacy from HINDU COLLEGE OF PHARMACY Acharya Nagarjuna university in 2013
  • pharmaceutical management and regulatory affairs in Pharmaceutical Marketing and Management and REGULATORY AFFAIRS from Hindu college of pharmacy in 2013
  • B.Pharmacy in B Pharm from Adhiparaasakthi College of Pharmacy MGR University in 2010
  • Bachelor of Pharmacy (B.Pharm.) in Pharmacy from ADHI PARA SAKTHI COLLEGE OF PHARMACY in 2010
  • M.Pharmacy in Pharma Management from IPA in 2010
  • INTERMEDIATE in BIOLOGY/PHYSICS/CHEMISTRY from Board of Intermediate Education in 2006
  • INTERMEDIATE in BIOLOGY,PHYSICS,CHEMISTRY from NLVRGSRVJr COLLEGE APRJC in 2006
  • TENTH in from Sri Devi Convent, TENALI Board of Secondary Education in 2004

Area / Region

Marathahalli, Bengaluru, Karnataka, India

Others

Driving License
  • No

Similar Candidates

Other Candidates in India

Other Candidates in Bengaluru

Other similar Candidates in Bengaluru

Other Candidates

Most Recent Searches

Most Famous Searches

You might also like