CHETAN G. JOSHI
Present Address : Aavas Apartment, 407 B, Mahalaxmi Nagar, B/H Kotak Mahindra Bank, Nr. Podar Kids School, Chala, Vapi, Gujarat-396191, India
Permanent Address :231, Shiv Colony, B/H Hero Honda Show Room, Udaipur Road, Banswara, Rajasthan – 327001
Contact : 9898599299, 9727508820 , 9950608830
Email add. :chetan99joshi_x AT yahoo.co.in
Overall 10 years experience in pharmaceutical industry of quality control department.
Possess ability and skills in :
DOCUMENTATION :
QMS Documentation :
** Plant Modification Form (PMF)
** Change Control
** Deviation
** Corrective Action and Preventive Action
** Incident Investigation as below,
Incidence :
** Out of Specification Result
** Out of Calibration
** Deviation
** GLP activities
** Motivate the junior, to right direction of future and company.
** Maintain laboratory instruments to ensure proper working order and troubleshoot when needed. Compile and analyze the test information to determine process or equipment operating efficiency.
** Analysis of Raw materials, Packing Material and Finish Product by using validated instrumental and conventional methods.
QUALITY CONTROL PROFESSIONAL - PHARMACEUTICAL INDUSTRIES AUDIT FACE :
USFDA, MHRA, WHO-Geneva and Domestic (CDSCO) , ANDA, MCC-SOUTH AFRICA,
NAFDAC-Nijeria, EU (Helmed)
RECENT AUDIT FACE :USFDA & EU (Helmed)
AREA OF INTEREST :
** Quality Control
** QA/QC
From Current Job :
1. UMEDICA LABORATORIES PVT. LTD. VAPI, GUJARAT
Job Responsibilities :
** Overall responsibilities of GLP activities as below,
** Working Standard / Reference Standard.
** Working Standard Qualification
** Procurement, Usage & Maintenance of HPLC / GC Column.
** Instrument Qualification - Software Qualification, Clint Qualification - Challenge test then Calibration & instrument qualified and ready for use.
** Instrument Calibration
** Soft Data Verification
** Analyst Qualification
** Training
** Instrument AMC / Preventive Maintainace.
** Procurement
** Review of Raw Data of Finish Product, Raw Material and Stability section.
Investigation & CAPA :
** Laboratories Incidence,
** Out of Specification Results
** Out of Calibration.
Designation :Sr. Executive QC
Date of Joining :Nov 2016
Date of Relieving :Till
2. OLIVE HEALTHCARE, UNIT-II, DAMAN, GUJARAT
Job Responsibilities :
** Overall responsibilities of Raw Material and Packing Material as below,
** Preparation of Specification & Standard Testing Procedure.
** Preparation of Work Sheet (Template)
** Review Raw Data of Raw Material & Packing Material.
** Release the Material.
** GLP activities as below,
** Calibration of instrument.
** Working Standard Qualification.
Investigate & CAPA :
** Laboratories Incidence,
** OOS
** OOC
Designation :Asst. Manager QC
Date of Joining :Mar. 2015
Date of Relieving :Nov 2016
3. RPG LIFESCIENCES LIMITED, ANKLESHWAR, GUJARAT
Job Responsibilities :
Stability :
Activities are :
** Preparation of stability study protocol, master stability schedule plan, monthly stability schedule plan and maintain trend data.
** In case of stability chamber over shoot investigate incident report and charge new sample as per ICH guideline.
** Bracketing / Matrix
** Review analytical data of Stability Study (then Raw Material and Finish Product)
** SAP Release.
** Daily work planning.
Documentation :SOP, Instrument Qualification, Log Sheet of RM & FP
** To Validate - excel sheet, preparation of worksheet, proper labelling in laboratory, as per schedule revised SOP & MOA to make track with updated guideline, instrument soft data back up as per schedule, maintain status of WRS, volumetric solution, column history, instrument history, impurity standard.
** Check randomly usage log book, calibration status, and preventive maintenance entry, outside calibration status label & etc.
** In absence of staff analysis of samples.
Designation :Q C Sr.
Executive
Date of Joining :Apr, 2013
Date of Relieving :Mar, 2015
4. CADILA HEALTHCARE LIMITED, ANKLESHWAR, GUJARAT :
Job Responsibilities :
** Calibration of all instruments as per schedule.
** Analysis of Reaction Mass sample, Raw Material, In-process, Intermediate and Finish product sample of HPLC and GC Samples.
** Preparation of USFDA Audit.
Instrument Handle :
** HPLC (Dionex Ultimate 3000 Chromeleon Software, Shimadzu 2010 LC Software),
** GC (Shimadzu 2010 and 2014 GC Solution Software), UV Visible Spectrophotometer(Shimadzu UV 1601), FTIR, Autotitrator (Metrom, Karl Fisher Metrom, pH meter Metllor Toledo)
Designation :QC Sr. Chemist
Date of Joining :May 2010
Date of Relieving :Apr. 2013
5. SUN PHARMACEUTICAL INDUSTRIES LIMITED, SILVASSA, DNH
Job Responsibilities :
** Calibration of all instruments as per schedule.
** Complete analysis of Stability sample and report in Lim’s Software,
** Charge stability sample as per SOP.
** Reconciliation of stability sample.
** Fill Incident report and Out Of Specification.
Preparation of Audit : ANDA, MCC SOUTH AFRICA, NAFDAC NIJERIA.
Instrument Handle :
** HPLC (Waters Alliance 2696 Software Empower, Shimadzu 2010 Software LC Solution),
** GC (Shimadzu 2010 and 2014 GC Solution Software and Shimadzu 14B Manual Injector), UV Visible Spectrophotometer (Shimadzu UV 1601, Dissolution Apparatus (Electrolab), Disintegration Test Apparatus, Hardness Tester, Friability Test Apparatus, Autotitrator (Metrom), Karl Fisher (Metrom), pH meter (Metllor Toledo).
Designation :QC Officer
Date of Joining :April 2008
Date of Relieving :May 2010
6. IPCA LABORATORIES LIMITED, SILVASSA, DNH
Job Responsibilities :
** Calibration of all instruments as per schedule.
** Complete analysis of Stability Sample and maintain micro analysis sample for stability.
** Preparation of Audit : MHRA, WHO Domestic & Geneva.
Instrument Handle :
HPLC (Waters Alliance 2696 Software Empower), Shimadzu 2010 Software LC Solution),UV Visible Spectrophotometer Shimadzu UV 1601, Dissolution Test Apparatus (Electrolab), Disintegration Test Apparatus, Hardness Tester, Friability Test Apparatus, Autotitrator (Metrom), Karl Fisher (Metrom), pH meter (Metllor Toledo)
Designation :QA Officer
Date of Joining :DECEMBER 2006
Date of Relieving :APRIL 2008
ACADEMIA :
** SSC Common 1997 Ajmer Board Nutan Higher Seiner Secondary School. 41 % IInd Division
** HSC Biology 1999 Ajmer Board Nutan Higher Seiner Secondary School. 41 % IInd Division
** B. Sc. Bio-chemistry 2006 Sardar Patel University, VV Nagar M.B. Patel Science College 43 % IInd Division
** M. Sc. Chemistry 2012 Madhurai kamraj University Madhurai Kamraj University, Vadodara 59 % IInd Division
PERSONAL DETAILS :
Father Name : Girijanshkar L. Joshi
Mother Name : Sushila G. Joshi
Marital Status : Married
Date of Birth : 23rd July 1981
Linguistic Ability : English, Gujarat and Hindi.
Favourite Sport :Cricket, Listing Music.
Date :
Place :