Track wise ,LIMS,SAP,Finedocs,Empower 3,Syngistix,Tiamo, Labsolutions,UV Probe,Newtronics,Spectrum ES,Chromeleon,Minitab
MAHESH DESHMUKH
Plot No:219/220B,Lane-2,Manohar Nagar, Talegaon Dabhade , Dist- Pune, Maharashtra-410507
Summary
Having a 20+ years of experience in Pharmaceutical QA/QC and analytical exposure to Oral solid dosages (Tablets, hard and soft gelatin capsules, Suspensions and Injections (PFS & Powdered) & Ophthalmics. Seeking a suitable position to utilize my skills and abilities in the organization for professional growth and to give best performance to the organization.
Overview
20
20
years of professional experience
5
5
years of post-secondary education
3
3
Certifications
1
1
Language
Work History
QA Manager
EMCURE PHARMACEUTICALS LTD, PUNE
12.2016 - Current
- Review and approval of investigation reports (failures obtained during analysis of Raw materials, Packaging materials , In-process , Semi finished products , Finished products / Stability study samples and calibration activities).
- Review and approval of Trend reports of laboratory events, OOS/OOT/OOC with respect to traits.
- Review and approval of quality system documents including SOP's , Specifications and CSV.
- Review and approval of protocols and reports of Instrument/Equipment qualification, Method validation.
- Review and approval for Working standard qualification protocols/reports, calibration planner, QC analyst/ QA reviewer certifications, excel sheet validation reports
- Review and approval for QA/QC SOP’s, laboratory instrument OI/calibration/audit trail review procedures and periodic audit trail reports.
- Actively participating and engaging for reducing human errors and ascertaining appropriate CAPA for repetitive Human errors.
- Performing Internal audits/Vendor audits.
- Ensuring Quality Systems and Standards are maintained in Quality unit.
- Ensuring Company’s Policy of Data Integrity and Ethics for Quality, Environmental Health and Safety is being implemented
- Training for cGMP and GDP to all personnel at site.
- Actively participating and engaging in regulatory audit of USFDA, MHRA, Health Canada,ANVISA, SAHPRA, TGA, WHO, ROW and Local FDA.
- Participation in Review of Site Master file (SMF) and Validation Master plan (VMP).
- To assist Site QA Head for replying the observations of Regulators, Internal/ External customer.
Asst. Manager QC
EMCURE PHARMACEUTICALS LTD, PUNE
05.2014 - 12.2016
- Daily work allocation of stability samples to analysts and concurrent verification of raw data
- Preparation and review of summary data sheets of stability samples
- Preparation of Excel sheets for quantitative analysis
- OOS/OOT investigations
- Preparation investigation summary reports and related documents
- Management of Reserve samples
- Preparation of SOPs for instrument operation and Quality Control procedures.
QC Executive
RANBAXY LABORATORIES LTD, DEWAS,MP
07.2012 - 05.2014
- Analysis of Commercial stability samples.(Tablets/Capsules/Suspensions- β Lactums & Penems)
- Management of stability samples
- Assistance in investigating OOS/OOT in stability department
- Preparing summary data sheets of stability samples.
Executive and Group leader
MARKSON PHARMA PVT LTD, GOA
03.2012 - 06.2012
- Planning of stability sample analysis (Tablets, Hard & Soft gelatin capsules)
- Review of analytical data
- Preparation of stability reports.
Jr.Executive
WATSON PHARMA PVT LTD, GOA
12.2010 - 03.2012
- Analysis of process validation samples.
- Maintaining the preventive maintenance record of HPLC systems.
- Timely completion of analytical method validation and method transfer activities.
- Timely completion of Analytical reports of validation batches
- Checking WS/RS/Impurities consumption records and suggesting cost cutting for unnecessary consumption of costly standards
- Gap analysis for methods
- Creation and validation of Calculation sheets.
Sr.Research Associate
WOCKHARDT LTD
AURANGABAD
05.2008 - 12.2010
- Analysis of stability samples (Tablets/Capsules/Suspensions/Injections)
- Management of under analysis stability samples
- Assistance in investigating OOS/OOT in stability study analysis
- Preparing summary data sheets of stability samples.
Sr.Officer
AJANTA PHARMA LIMITED
AURANGABAD
08.2005 - 04.2008
- Daily work allocation to analysts in stability
- Maintaining data of Stability chambers
- Preparing stability protocols & Charging of the samples in Stability Chambers
- Analysis of stability samples as per schedule
- Preparation of monthly & yearly schedules for charged stability samples
- Testing of Finished and Stability samples (Oral solid dosages)
- Involvement in Analytical Method transfer of products from R&D to QC.
QC CHEMIST
ENCORE HEALTHCARE PVT LTD
AURANGABAD
10.2002 - 07.2005
- Charging and withdrawal of Stability samples
- Analysis of stability samples,raw material samples.
- Compilation and review of supporting documents for stability analysis
- Preparation of stability data summary sheets
- Management of chemicals / laboratory consumables
Education
B.Sc - Chemistry
Art, Science & Commerce College
Rahuri, Ahmednagar- Maharashtra 06.1996 - 07.1999
Master of Science - Organic Chemistry
Pune University, Ahmednagar College , Ahmednagar Pune University
Ahmednagar-Maharashtra 07.1999 - 08.2001
Skills
Auditing
QMS & QMM
Staff training and development
CGMP
Six Sigma
Quality Compliance
Software
Certification
Certified Trainer, Emcure pharmaceuticals Ltd, Pune
Awards
- Best student of Science award consecutively for 3 years (FY, SY & TY) at college level.
Traingings
- Attended various seminars and programs on Stability study, Train the Trainer, Team building, Time management, Leadership skills, Laboratory Investigations, QMS documentations , Statistical data analysis etc.
- Participated in meetings with MERIDAN Consultants, USA at Emcure (Pune) for improvements.
- Certified as Trainer through 'Train the trainer' programme.
Personal details
- Date of Birth : 06 August 1976
- Nationality : Indian
- Permanent address : A/P-Deolali Pravara,Tal - Rahuri, Dist- Ahmednagar, Maharashtra 413716
- Marital Status : Married
- Hobbies/Interest : Playing cricket, badminton. Attend Pharmaceutical webinars/seminars. Reading religious and scientific literatures.
Timeline
QA Manager
EMCURE PHARMACEUTICALS LTD, PUNE
12.2016 - Current
Asst. Manager QC
EMCURE PHARMACEUTICALS LTD, PUNE
05.2014 - 12.2016
QC Executive
RANBAXY LABORATORIES LTD, DEWAS,MP
07.2012 - 05.2014
Executive and Group leader
MARKSON PHARMA PVT LTD, GOA
03.2012 - 06.2012
Jr.Executive
WATSON PHARMA PVT LTD, GOA
12.2010 - 03.2012
Sr.Research Associate
WOCKHARDT LTD
05.2008 - 12.2010
Sr.Officer
AJANTA PHARMA LIMITED
08.2005 - 04.2008
QC CHEMIST
ENCORE HEALTHCARE PVT LTD
10.2002 - 07.2005
Master of Science - Organic Chemistry
Pune University, Ahmednagar College , Ahmednagar Pune University
07.1999 - 08.2001
B.Sc - Chemistry
Art, Science & Commerce College
06.1996 - 07.1999