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Quality Control

Location:
Mumbai, Maharashtra, India
Posted:
November 10, 2018

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Resume:

CURRICULUM VIATE

Name :- YOGESH .SHANKARSINGH. RAJPUT.

Permanent Adress :- C/O .Kamleshsingh .S. Rajput., Indraprak, Bldg 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 (W) Pin-421301.

Email: ac7nnq@r.postjobfree.com • Mob: +91-900*******.

Nationality : - INDIAN .

Marital Status :- Married.

Date of Birth: 13 August 1978.

Passport No: G 8731994.

Languages Known :- English, Hindi & Marathi.

Educational Qualification :-

Sr no

Education

School /College

University/

Board

Year of passing

Class

1

Msc Part-II(Chemistry)

Vinayka Missions University

Vinayka Missions University

June 2012

I

2

Msc Part-I (Chemistry)

Vinayka Missions University

Vinayka Missions University

June 2011

I

3

Bsc (Chemistry)

CHM College

Mumbai

May 2000

II

4

HSC

Hindi Junior College

Pune

March 1996

II

5

SSC

Lourdes High School

Pune

March1994

II

Experience :-

Sr no

Name Of Organisation

Designation

Working Period

1

Arch Pharmalabs Corporate R & D centre .

Working as ADL EXECUTIVE (Annalytical Development Department)

(Nov 2006 till date).

2

Jannsen Cilag Pharmaceuticals Ltd, Johnson & Johnson Ltd.

Quality Control Officer

( Stability Department )

(Aug 2005 till Sep 2006 ).

3

Glenmark Reasearch centre, Glenmark Pharmaceuticals Ltd .

Quality Control Chemist

( Quality control Department )

(Jun 2004 till Aug 2005 ).

4

Sekhseria chemicals Ltd, Pharma division.

Quality Control Chemist

( Quality control Department )

(Jan 2003 till Jun 2004 ).

5

Pharmasolve Specialities India Pvt Ltd( CIPLA), Pharma division.

Quality Control Chemist

( Quality control Department )

(Aug 2001 till Dec 2002 ).

Total Experience :- 17 Years of experience in Formulation & API analysis.

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 15 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 ADL EXECUTIVE in Annalytical Department (Analytical) at Arch Pharmalab Ltd corporate R&D centre.

Research & Development

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.

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 for higher productivity and efficiency.

Responsible for investigating the unusual / unacceptable 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:

Involved in Annalytical Method Development Study for Finished products & API and 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 and Autotitrator.Dissolution apparatus & Instruments used in pharma industry quality control

oTest methods development for organic volatile impurities.

oMethod validation of Active pharmaceutical ingredients.

Lead the upgraded test procedures for:

oVarious drug substances as per pharmacopial 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

Played an instrumental role in the calibrations of instruments like HPLC, GC, UV & IR.

Distinction in managing analytical instruments (IQ, OQ, PQ) and calibration of analytical instruments by following standard operating procedures.

Pioneered the stability studies for API and Intermediates, formulation product as per the ICH guidelines.

Effectively dealt with audits like FDA, Irish Audit.

References:-

1)Mr . Sushil Bhagwan.

Designation:-Deputy Manager QC.

Company :- Serum Institute of Poonawala.

Mobile no:-91-982*******.

2)Mr . Prabhakar Tichgey.

Designation:- QC Incharge.

Company :- Deccan Neutraceuticals (P) Ltd.

Mobile no:-+91-952*******.

CV d see Dr.

( Yogesh . Shankarsingh . Rajput )

Bhkmb



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