Qc Manager Assistant
Resume:
Curriculum Vitae
Name: Yogesh Shankarsingh Rajput
Seeking a challenging Senior Position in Quality Control/Analytical Development in the Healthcare, Pharmaceutical company & Research and Development Centre.
Permanent Address:
C/o Kamleshsingh S. Rajput, Indraprak, Bldg. No. A,
2nd Floor, Flat No. A - 21,
Hanuman Mandir lane,
Hadapsar, Gadital, Pune 411028.
Present Address:
Shree Complex, Phase-I, Block No.20,
Building No.A-4/B, Adharwadi Jail Road,
Kalyan (West) Pin 421301.
Email: **************@**********.***
Mob: +91-900*******.
Nationality: Indian.
Date of Birth: 13 August 1978.
Passport No: G 8731994.
Languages Known: English, Hindi and Marathi.
Educational Qualification:
Sr.
No.
Education
School /College
University/
Board
Year of passing
Class
1
M. Sc. Part-II(Chemistry)
Vinayka Missions University
Vinayka Missions University
June 2012
I
2
M. Sc. Part-I (Chemistry)
Vinayka Missions University
Vinayka Missions University
June 2011
I
3
B. Sc. (Chemistry)
CHM College
Mumbai
May 2000
II
4
HSC
Hindi Junior College
Pune
March 1996
II
5
SSC
Lourdes High School
Pune
March1994
II
Page 2 of 4
Experience:
Total Experience: 18 Years of experience in QC/ADL Lab of Pharmaceutical Formulations & APIs.
Sr. No.
Name Of Organization
Designation
Working Period
1
Pioneer Agro industries Pvt Ltd,
( Pharma Division )
Working as Asst ADL /QC Manager (Analytical Development Department/Quality Control Department)
Feb 2019 till date
2
Arch Pharmalabs Corporate
R & D Centre.
Working as ADL Executive (Analytical Development Department)
Nov 2006 till Jan 2019
3
Janssen Cilag Pharmaceuticals Ltd., Johnson & Johnson Ltd.
Quality Control Officer
(Stability Department )
Aug 2005 till Sep 2006
4
Glenmark Research Centre, Glenmark Pharmaceuticals Ltd.
Quality Control Chemist (Quality control Department )
Jun 2004 till Aug 2005.
5
Sekhseria chemicals Ltd., Pharma Division.
Quality Control Chemist
(Quality control Department )
Jan 2003 till Jun 2004
6
Pharmasolve Specialities India Pvt. Ltd. (Cipla), Pharma Division.
Quality Control Chemist
(Quality control Department )
Aug 2001 till Dec 2002
Seeking a challenging Senior Position in Quality Control/Analytical Development
in the Healthcare, Pharmaceutical company & Research and Development Centre.
Formulation & API manufacturing Company and R&D Centre.
Profile at a Glance:
Over 18 years of experience in analysis of raw materials, API and finished products like tablets, creams, gel, and ointment of Healthcare and Pharmaceutical sectors.
Hands on experience in MS-Word, MS-Excel.
Expertise in facing different types of Audits and visits.
Knowledge of method validation of Pharma & Bulk Drug Products as per ICH guidelines.
Knowledge of change control system & out of specification.
Well aware with stability ICHguideline for pharma products as well as bulk drug products.
Rich experience in Process validation of finished product, API & Formulation .
Currently working as Assistant ADLManager/QC manager in Analytical Department (Analytical) and Quality Control Department at Pioneer Agro Industries Pvt Ltd, Pharmaceutical Division,Sanvin Group.
Page 3 of 4
Analytical Development Lab.:
Method development for new molecules as per stages requirements of Route of Analysis.
Rigorous testing of the methods to ensure that they are precise, accurate, reproducible and Product specific.
Preparation of method validation protocols and reports, stability protocols.
Reviewing detailed documents explaining about the work and its results
Participation in Product/ Process Improvement
Ensure complete in-process quality control and continuous improvement in process capabilities.
Routine maintenance, calibration and troubleshooting for analytical equipment on a regular basis
Responsible for investigating the unusual / OOS QC Test results
Documentation/Quality Compliance
Ensure compliance of various quality measures such as GLP by maintenance of appropriate requisite records.
Preparation of SOP’s for instruments and calibration of instruments.
Key Responsibilities:
Analytical Method Development for APIs, Finished products and Equipment cleaning validation.
Analytical method validation & Development of API and Finished product.
Stability studies for Finished product& API .
Successfully Performing installation, operational & performance qualification for instruments.
Preparing of sop\'s for operation & calibration of various instruments.
Effectively Maintaining history cards for servicing of different instruments.
Dealing with different contractors for annual maintenance of different instruments.
Key Achievements:
Played a pivotal role in the analysis of:
oActive pharmaceutical ingredients, Raw Materials, Intermediates and Formulation products by using analytical instruments like HPLC, GC, FTIR, UV/ VIS Spectrophotometer, Autotitrator Dissolution Test apparatus & other instruments used in Pharma Quality Control Laboratory
oTest methods development for organic volatile impurities
oMethod validation of Active pharmaceutical ingredients
Developed upgraded Test procedures for:
oVarious drug substances as per pharmacopoeial supplements.
oAnalytical Test Methods complying guidelines from ICH and USP-26 by following steps mentioned in guidelines like Accuracy, Precision, Specificity, Limit of Detection, Limit of quantification, Linearity and Range, Ruggedness and Robustness.
oOVI and Residual solvents by Gas Chromatography
Well versed with calibrations of instruments like HPLC, GC, UV & IR.
Distinction in managing analytical instruments (IQ, OQ, PQ) and calibration of analytical instruments
Initiated stability studies for API and Intermediates, formulation product as per the ICH guidelines
Effectively dealt with audits like WHO-GMP, USFDA, Irish Audit
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References:
1)Mr. Sushil S Bhagwan
Designation : Assistant Manager,
Company : Serum Institute of India Ltd., Pune.
Mobile No. : +91-982*******
2)Mr. Bhushan S. Rajput.
Designation : Deputy General Manager,
Company : Glenmark Pharma, Goa
Mobile no : 838*******
3)Mr. Savio Dorado
Designation : Head, Corporate Quality
Company : Cipla Ltd, Mumbai
Mobile No. : +919*********
Yogesh Shankarsingh Rajput
Contact this candidate