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[QUOTE=Unregistered;294288]KESKAR NAGNATH BALKRUSHNA
[b][u]E-mail  [/u][/b]: keskar2011 AT hotmail.com / nagnath72 AT rediffmail.com

[b][u]Professional Summery  [/u][/b]:
** Professional experience of 15 years in Pharmaceutical Industry As Analyst (Q.C.) / Senior Analyst/ Q.C. In charge with different organizations

Working with UMANG PHARMATECH PVT.LTD Vasai as a Q.C Head from 20 March 2010 to till date.

** Worked with JASMIKA HEALTH CARE PVT LTD VASAI AS A Q.C. In charge from April 2009 to March 2010

** Worked with UNIBIOS LOBORETORIES LTD as Q.C. In charge Duration- From Aug 2006 to March 2009

** Worked with LIBERAL PHARMACEUTICAL at Palghar as Q.C. In charge. Duration - Dec 2003 to July. 2006

** Worked with RICHIE LABORETORY LTD. at Vasai as Chemist Duration - Nov.1999 to May. 2003

** Worked with M.J.LABORETORIES as Trainee Chemist Duration - Dec.1997 to Oct. 1999

[b][u]Educational Qualification  [/u][/b]:
** B.Sc.(Chemistry) passed with second class from Pune university April 1997
** M.Sc. (Chemistry) passed with First class From Vinayaka Mission University Tamilnadu May 2012

[b][u]Technical Qualification  [/u][/b]:
** Having FDA approval in Chemical & Instrument department From FDA Thane (Maharashtra)
** Having FDA approval in Microbiology department from FDA (Thane) (Maharashtra)
** Certificate course in Computer (M.S.C.IT)

[b][u]Skill summery  [/u][/b]:
[b][u]** Analyst Q.C. [/u][/b]:
** Handling Spectrophotometer U.V. Visible model Jasco V 530,
** Shimadzu 1201,1701 ,1700 Elico SL-159 , UV Visible
** Spectrophotometer SYS 118
** FTIR ( PerkinElmer, Jasco-410, Nikolite 380)
[b][u]** HPLC [/u][/b]: Model : Jasco,UV 975,PU980 Water 486 ,510( Win Chrome )
** Agilent 1120Compact LC,( Ezichrome Elite Software) Auto sampler
** Shimadzu LC-2010( LC Solution Soft ware )
[b][u]** GLC [/u][/b]: Perkin Elimer With FID ( Iris 32 )
** Karl fisher (Vego,Lab India )Flame photo meter, Dissolution
** Apparatus(Vego, Lab India Disso 2000),Florimeter
** Potentiometer,(Vego),pH meter& other laboratory instrument

[b][u]Audit Handled  [/u][/b]:
** WHO Audit Role as a Q.C. Head total responsibility of Quality Control in Jan 2010 In Ms Jasmika HealthCare Pvt Ltd Vasai & Jan 2009 in Ms Unibios Lab Ltd Palghar
** NAFDAC Audit ( Nigeria ) Role as a Q.C.Incharge In Feb 2010 in Jasmika Health Care Pvt Ltd Vasai. 
** NDA Audit ( Uganda ) Role as a Q.C .Manager In Feb 2009 in Ms Unibios Lab Ltd Palghar
** ISO 22000 { HACCP } Role as a Q.C. Head Audit in March 2011 in Umang Pharmatech Pvt Ltd Vasai
 ** Iran Daru Pharmaceuticals ( Iran ) audit Q.C. Head Audit in March 2013 in Umang Pharmatech Pvt Ltd Vasai
** Themes Medicare / Merck audit Q.C. Head Audit in March 2013 in Umang Pharmatech Pvt Ltd Vasai

[b][u]Professional training  [/u][/b]:
** Training on Lab Quality system Accreditation as per ISO 22000 at Mumbai.
** Training on Handling & development of Analytical method on different Instrument at Mumbai
** Training on Computer System Validation CFR 21 Part II by IBC Mumbai

[b][u]Job Description  [/u][/b]:
[b][u]** Present Employer  [/u][/b]:
[b][u]Organization  [/u][/b]: UMANG PHARMATEC PVT.LTD VASAI
Umang Pharmatech Pvt Ltd is GMP approved unit manufacturer of Pharmaceuticals,Nutra and cosmetic pellets,extrude& Mouth dissolving Film For domestic as well as export purpose.
 [b][u]Designation  [/u][/b]: Q.C.Head
 [b][u]Duration  [/u][/b]: From 20 March 2010 to till date
[b][u]Responsibilites [/u][/b]:
1. Handling about 10 – 15 analytical team and coordinating with about 4 member Analytical QA
2. Monitor analytical activities and experiments in support of the development, including method development, method validation, method transfer, compatibility studies and stability tests as per ICH, MHRA, USFDA, etc…guidelines.
3. Responsible for timely deliverables of laboratory activities related to Chemical, Instrumentation and microbiology testing
4. Provide oversight on environmental monitoring and microbiology during facility validation activities.
5. Ensure laboratory compliance.
6. Ensure regulatory and customer inspections readiness; represent area and participate in audits.
07. Ensure compliant and timely testing of samples received at laboratory and stability samples.
08. Ensure Stability studies and reports are compliant and timely.
09. Evaluate analytical raw data and laboratory analysis.
10. Ensure quality control department and equipment is maintained and reliable.
11. Ensure necessary equipment qualification and validations are complete.
12. Ensure the necessary training within the department is carried out and modified according to need.
13. Monitor and control method performance.
14. Designate and monitor the storage conditions for materials and products.
15. Maintaining Laboratory in compliance with the requirement of cGMP & cGLP and WHO.
16. Preparation and Review of SOP, STP, GTP, Specifications, protocols, etc.
17. To ensure that organization policies and disciplines are implemented and maintained effectively.
18. To notify the management in case of OOS, OOT, Deviation, Change control and to fill the required documents.
19. Timely Investigation and closure of all such notifications with CAPA.
20 To update the system as and when required due to any change, revision in regulatory guideline, pharmacopeias, or any additional customer requirement.
21. Define roles, responsibilities, project scope, timelines and deliverables. Track progress of projects within agreed timelines.
22. Directs Work Instructions to analysts for the testing and analysis of Stability Develop and administer schedules, assign responsibilities within the group Document all laboratory work to meet regulatory standards and perform data Review.
[b][u]23. Stability testing [/u][/b]: Protocol design, Long - term stability test, Drug substance stability testing, Comparator stability testing, Formulation evaluation stability testing, data trending, Forced degradation studies, Photo stability, Temperature cycling.
24. Collect, analyze and interpret data, keep records of experiments including results and conclusions, recognize aberrant results and data trends, and provide plausible explanations including plans for follow up experiments to clarify findings.
25. Assign and perform training and development goals to the group.
26. Achieved deliverables and contributed to meet targets for each quarter.
27. Successfully initiated and executed stability studies with detail trending and investigation.
28. Designed experiments and delivered results, demonstrating awareness of customer demands and focus.
[b][u]Reporting [/u][/b]: Reports to COO

[b][u]Past employers  [/u][/b]:
 [b][u]ORGANIZATION  [/u][/b]: JASMIKA HEALTH CARE PVT. LTD VASAI
WHO GMP approved pharmaceuticals formulation unit. Manufactured general tablets & capsules for export purpose
 [b][u]Duration [/u][/b]: From April 2009 to march 2010
 [b][u]Designation  [/u][/b]: Q.C. In charge
 [b][u]Responsibilities [/u][/b]:
** Responsible for total Q.C. department as a Head for third party as well as FDA & other regulatory audits
** Total responsibility of maintain documents, analysis& daily activity in Q.C. Department
** Distribution of work in chemist of chemical, instruments & microbiological
** Department.
** Responding to the Technical Queries of Chemists
** Preparation of Standard operating procedures
** Report cheking and sinning as authorized person
** Responding to the technical quires of the customers
** Responding to the Technical Queries of clients .

[b][u]ORGANIZATION  [/u][/b]: MS UNIBIOS LABORATORIES LTD PALGHAR
 [b][u]Duration  [/u][/b]: From August 2006 to march 2009
WHO GMP approved pharmaceuticals formulation unit. Manufactured general & betalactum tablets & capsules for export and domestic purpose
 [b][u]Designation  [/u][/b]: Q.C.In charge
** Responsible for total Q.C. department as a Head for third party as well as FDA & other regulatory audits
** Total responsibility of maintain documents, analysis& daily activity in Q.C. Department
** Distribution of work in chemist of chemical, instruments & microbiological

** Department.
** Responding to the Technical Queries of Chemists
** Preparation of Standard operating procedures
** Report checking and sinning as authorized person
** Responding to the technical quires of the customers
** Responding to the Technical Queries of clients.

[b][u]Organization  [/u][/b]: Liberal pharmaceuticals at palghar
Manufacture of Tablets, Capsules Liquid oral & ointment for export & domestic purpose
 [b][u]Designation  [/u][/b]: Quality control in charge
 [b][u]Period  [/u][/b]: June 2003 to July. 2006
 [b][u]Responsibilities  [/u][/b]:
** Job allocation of chemists
** Checking Analytical reports, B.M.R., Packing material etc.
** Supervision of different I P Q C work
** Proper supervision in Production & Q.C. department

[b][u]Organization  [/u][/b]: Richie Lab Ltd . (vasai)
 [b][u]Designation  [/u][/b]: Junior Chemist
 [b][u]Duration  [/u][/b]: Nov.1999 to May. 2003
Richie Laboratory was WHO approved formulation company they have three sections
Tablets, Capsules , Liquid oral They manufacture for Govt supply
[b][u]** Responsibilities  [/u][/b]: Sampling of raw material as per SOP 100 % sampling for API and for expients use Square root n+1 formula
** Analyzing raw materials , finished products , as per procedure
** Keeping stability , validation records Working in Microbiology department caring out sub culturing , microbiological Assay of Antibiotics, Idn of E-coli, salmonella in DM
** water and other Compound Making record of plate count, sub culturing, media preparation, swab test, Incubator, etc.
** Working on HPLC , IR , GLC

[b][u]Organization  [/u][/b]: M.J. Laboratories ,Wada
 [b][u]Designation  [/u][/b]: Trainee Chemist
 [b][u]Duration  [/u][/b]: Dec.1997 to Oct. 1999
M.J. Laboratories was FDA approved public testing Laboratory. They can carry out Different type of pharmaceutical , cosmetic testing
 [b][u]Responsibilities  [/u][/b]:
** Preparation of volumetric solutions and general reagents
** Analyzing Raw material , finished products ,vitamins ,
** Working in instruments department under supervision of expertise.
** Handling HPLC,GLC , U.V. , IR .

[b][u]Personal information  [/u][/b]:
[b][u]Name  [/u][/b]: Mr. Keskar N. B.
[b][u]Date of Birth  [/u][/b]: 5/6/1972
[b][u]Marital status  [/u][/b]: Married
[b][u]Lang wages Known  [/u][/b]: Marathi , English ,Hindi
[b][u]Hobby [/u][/b]: Reading & Playing

[b][u]Declaration  [/u][/b]:
I here by declare that all the statement furnished here are true to the best of my knowledge
[b][u]Date  [/u][/b]:
[b][u]Place  [/u][/b]: 
N.B.Keskar.[/QUOTE]

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