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[QUOTE=Guest-IJT;99919]Trupti Patil
trupti.patil01 AT gmail.com
Quality Assurance

Ms. TRUPTI ASHOK PATIL.
[b]Tal.- Karad Dist [/b]: Satara.
Maharashtra.
trupti.patil01 AT gmail.com 
 
CAREER SNAPSHOT
Seeking position in an organization where I can apply my thoughts and skills for the development of the organization as well as my personal growth.
EXPERIENCE DETAILS
- Working in Quality Assurance as management staff in Cipla Goa Unit III, Plot No.L-143 and L-144, Verna Industrial Estate, Salcette, Goa –403722 from date May24, 2007 to till date.
- Worked in a Quality Control Department as QC Executive for Six month in Lupin Limited, B-15, and phase 1A Verna Industrial Estate, Salcette Goa -403722. from date November 23, 2006 to May22, 2007.
- Worked in a Quality Control Department for two and half year as a Section Head in Okasa Pharma (Cipla Ltd.) Private limited,L-2 additional MIDC area Satara -415004 from date March 05, 2004 to September 02, 2006.
- One and half month in plant training in Mediorals Labs. Pvt. Ltd . , J-4/2 Additional MIDC, Satara – 415004.
SPECIAL ACHIVEMENT
- FDA Approval in Chemical and instrumental analysis.
ACADEMIC DETAILS
Examination Institute / University Year Percentage
Advance Diploma in Pharmaceutical Quality Assurance Management Institute Of Pharmaceutical Education and Research, Pune. (Maharashtra).
 09.10.2006 56.00%
Maharashtra state Certificate in information Technology Maharashtra State Board of Technical Education, Mumbai. 05.01.2005 83.75%
B.Pharmacy Satara College of Pharmacy, Nigadi,
Dist-Satara, Shivaji University, Kolhapur (Maharashtra) 
31.12.2003 
65.75 %
COMPUTER SKILLS
Knowledge of MS Office, Power point Excel, Internet operations.
CO-CURRICULAR ACTIVITIES
Participate in 54 th Indian Pharmaceutical Congress 2002.
JOB RESPONSIBILITIES
[b]1. Job Profile in Okasa Pharma ( Solid and injectable Dosage form) [/b]:
[b]- Instruments Handled  [/b]:
[b]o HPLC  [/b]: Shimadzu, TSP, Agilent, Dionex 
[b]o GC  [/b]: Chemito 8610 HT, Perkin Elmer
[b]o TOC  [/b]: Shimadzu (TOC VCSH)
[b]o IR  [/b]: Shimadzu (FTIR 8300)
[b]o Melting Point  [/b]: Lab India
[b]o Dissolution Test Apparatus  [/b]: Lab India, Electra lab.
[b]o Autotitrator  [/b]: Methrohm.
[b]o KF Coulometer  [/b]: Methrohm
- Qualification, Calibration, and SOP of Instrument and Equipment.
- Preparation of the working standards and Test standards.
- Testing of Validation, Raw Material, Finished Products, and Stability Samples.
[b]- Audit Faced [/b]: FDA Inspection, WHO, TGA.
[b]2 Job profile in Lupin Ltd ( Solid Dosage form) [/b]:
[b]- Instruments Handled  [/b]:
[b]o HPLC  [/b]: Dionex
[b]o GC  [/b]: Perkin Elmer
[b]o TOC  [/b]: Shimadzu (TOC VCSH)
[b]o Melting Point  [/b]: Lab India
[b]o Dissolution Test Apparatus  [/b]: Lab India, Electra lab.
[b]o Autotitrator  [/b]: Methrohm.
o KF Coulometer : Methrohm
- Qualification, Calibration, and SOP of Instrument and Equipment.
- Preparation of the working standards and Test standards.
3 Job profile in Cipla Unit –lll Goa ( Solid Dosage form) :
- Creating and Handling quality system and procedure.
- Fulfillment of current needs of Training with respect to cGMP, GLP and GEP.
- Handling of Complaint, Deviations ,Change Controlsand CAPA.
- Participate in investigation of deviation, Complaints and out of specification test result.
- Establish and approval process validation and cleaning validation programme.
- General document preparation including Product History File, APQR, Flow sheet, Master protocol and report.
- Batch Record review.
- Rejection Handling.
- Dossier review and ensuring the sourcing of material, manufacturing and testing is carried out as per dossier.
- Co-ordination with RA for the document required by them for purpose of registration. 
- Risk assessment: FMEA.
- Self inspection of all departments. 
- Audit Faced : MCA, MCC, FDA Inspection, WHO,TGA,USFDA,MHRA .
TRANING ATTENED
 
- Training attended of Dr. Nilgel Halls , UK, GMP, Consultant, Australia on different topics such as Microbiology Aspects of Cleaning Validation , Detection of Objectionable Microorganism, Investigation of Microbiology failure ,Identification of Microorganisms media fill , Changes of FDA etc.
- Training attended of Mr. Derek Smith, GMP, Consultant, Ex.Inspector, TGA, Australia on Cleaning validation.
- Training attended of Michael Ansifiled Director of Globepharm on Risk Management, OOS Investigations and CAPA, Global Regulatory Affairs.
- Training attended of Dr. Nrapentra Nath Avenue, a Grange Park on Sterility Assurance review.
- Training attended of Mr. Destin LeBlanc on Cleaning validation.
- Training attended of Kent Faul Lachman Consultant, Services Inc on Best Practices in performing effective investigation for OOS results and extraneous peak to meet current FDA expectation.
- Training attended of Ziva Abraham , Micro rite, Inc on Microbiology laboratory practices.
- Training attended of Randy Hutt ,Lachman Consultant, Services Inc on Aseptic Processing an Investigation in Aseptic processing
CTC
Current : 5.0 lac per Annum.
Expected CTC : 7.0 to 8.0 lac per Annum Negotiable
 
 
Ms. Trupti A. Patil
Date
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Place 
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More Information about this submission and submitter:-
___________________________________________________
Submission ID : 4105176
Date & Time : 8th May 2011 4:27 AM (UTC)
IP Address : 223.191.162.200
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