Summary
Overview
Work History
Education
Skills
Areas Of Interest
Roleresponsibility
Instruments Used
Personal Information
Languages
Timeline
Generic

SUSHEEL KUMAR YADAV

Indore

Summary

9+Years Exp. in QC Department and 2+Years Exp. in QA Department in Pharma Companies. Present Employer Mylan Labs Ltd in Quality Assurance Department.I Handled Instruments like HPLC (Make Waters Model 2695 with auto sampler). HPLC (Make Dionex Model Ultimate 3000) U.V. (Make SHIMADZU Model 1800). FTIR (Make SHIMADZU). Disintegration test apparatus. Dissolution test apparatus with auto sampler. KF Apparatus PH Meter (Make CYBERSCAN). Analytical Balance (Make Metter Toledo). Role and Responsibility with Present Employer is Review and approval of analytical data generated in the QC department, ensuring accuracy and compliance with SOPs, GMP, and regulatory requirements.handle the shift operation. Generation of Certificate of Analysis (COA) and result recording in SAP. Verification of Certificate of Analysis (COA) and result recording in LIMS.Verification of OOS and OOT criteria.

Overview

15
15
years of professional experience

Work History

AQA Reviewr

Mylan Labs Ltd
INDORE
08.2015 - Current
  • Review and approval of analytical data generated in the the Quality Control department, ensuring accuracy and complience with SOP's, STP, GMP and regulatory requirements.
  • Conduct thorough audits of analytical methods and test results, identifying discrepancies and implementing corrective actions.
  • Collaborate closely with the Quality Control team to provide guidance on complex analytical issues.

Quality Control Analyst

Lupin Ltd
Indore
07.2011 - 07.2015

Unichem Labs Ltd
Ghaziabad
10.2009 - 07.2011

Education

B.Pharmacy -

I.T.S. Paramedical College Muradnagar Ghaziabad Approved by A.I.C.T.E., Uttar Pradesh Technical University Lucknow

10+2 -

Public Inter College, Kerakat, Jaunpur

10th -

S.G.High School, Murkha Dobhi, Jaunpur

Skills

  • Review and approval of analytical data
  • Instruments Handled:-
  • HPLC (Waters Model 2695 with auto sampler, Dionex Model Ultimate 3000)
  • UV Spectrophotometer (SHIMADZU Model 1800)
  • FTIR (SHIMADZU)
  • Disintegration and Dissolution Test Apparatus with auto sampler
  • KF Apparatus
  • pH Meter (CYBERSCAN)
  • Analytical Balance (Metter Toledo)

Software Proficiency

  • SAP
  • CARA Documentum Software
  • Trackwise
  • LIMS
  • Microsoft Office Suite (Word, Excel, PowerPoint

Areas Of Interest

  • Quality Control (Q.C.)
  • Quality Assurance (Q.A.)

Roleresponsibility

  • Review and approval of analytical data generated in the QC department, ensuring accuracy and compliance with SOPs, GMP, and regulatory requirements.
  • Verification of OOS and OOT criteria in LIMS and handle of OOS and OOT in Trackwise Investigation Software
  • Identify root cause on non-conforming materials to identify problems and Plan corrective action.
  • Coordination and assisted manufacturing and QA department and handle the shift operation
  • Verification of Certificate of Analysis (COA) and result in SAP and LIMS.

Instruments Used

  • HPLC (Make Waters Model 2695 with auto sampler)
  • HPLC (Make Dionex Model Ultimate 3000)
  • U.V. (Make SHIMADZU Model 1800)
  • FTIR (Make SHIMADZU)
  • Disintegration test apparatus
  • Dissolution test apparatus with auto sampler
  • KF Apparatus
  • PH Meter (Make CYBERSCAN)
  • Analytical Balance (Make Metter Toledo)

Personal Information

  • Father's Name: Mr. A.P.YADAV
  • Date of Birth: 02/05/83
  • Marital Status: Married

Languages

Hindi
First Language
English
Intermediate (B1)
B1

Timeline

AQA Reviewr

Mylan Labs Ltd
08.2015 - Current

Quality Control Analyst

Lupin Ltd
07.2011 - 07.2015

Unichem Labs Ltd
10.2009 - 07.2011

B.Pharmacy -

I.T.S. Paramedical College Muradnagar Ghaziabad Approved by A.I.C.T.E., Uttar Pradesh Technical University Lucknow

10+2 -

Public Inter College, Kerakat, Jaunpur

10th -

S.G.High School, Murkha Dobhi, Jaunpur
SUSHEEL KUMAR YADAV