www.kopran.com Kopran Laboratories Ltd Mahad : QUALITY CONTROL EXECUTIVE

[mskavi]

Kopran Ltd Mahad : OFFICER / EXECUTIVE - QUALITY CONTROL

Website: http://www.kopran.com

Keywords: QA / REGULATORY API, FDA APPROVED

Designation: OFFICER / EXECUTIVE - QUALITY CONTROL
Experience: 2 - 4 Years
Location: Mahad

Job Description:
Candidate shall be responsible to prepare, implement & present QA documentary systems to various inspection/auditing agencies for Sterile & Non-Sterile API manufacturing facility. Online auditing of API facilities as per cGMP requirement.

Desired Candidate Profile:
Candidate should have first class academic career from reputed institution. Should be ready to work in shifts & computer literate. Preferably FDA approved. Knowledge of USFDA, EDQM, TGA, WHO, cGMP & documentation is essential.

Company Profile:
An Indian Multinational Pharmaceutical Company with state of the art Plants for the manufacture of Active Pharmaceutical Ingredients and Finished Dosage Forms, having exports to over 50 countries.

Address:
Finished Dosage Forms : Khopoli
Village Savroli,
Taluka: Khalapur, Khopoli,
District: Raigad,
Maharashtra (India)
Tel: (91-2192) 274025 / 30.
Fax: (91-2192) 274031.
E-mail: rashid@kopran.com


Active Pharmaceutical Ingredients : Mahad
K-4/4, Additional M.I.D.C.,
Village Birwadi,
Mahad - 403 201,
District: Raigad, Maharashtra (India)
Tel: (91-2145) 251096 / 97
Fax: (91-2145) 251100
E-mail: cmsinghi@kopran.com


Kopran Laboratories Ltd.
Parijat House,
1076, Dr. E. Moses Road, Worli,
Mumbai - 400 018.
Maharashtra (India)
Tel: (91-22) 2494 0656 / 6662 7000.
Fax: (91-22) 2490 2521
E-mail: kopmed@vsnl.com


Kampala Pharmaceutical Industries (1996) Ltd.
Registered Office:
Plot No. M444/B,
Stretcher Road,
Ntinda, Kampala, Uganda
Tel: 256 41 222721 / 285645
Fax: 256 41 220129
E-mail: mail@kpi.co.ug

Email Address:
jobs@kopran.com


Keywords: QA / REGULATORY API, FDA APPROVED

[Guest]

Curriculum Vitae
Ms. Sonali Pandurang Burkule

E-mail : sonaliburkule AT gmail.com
CAREER OBJECTIVES

Wish To Take Up Challenging Jobs Where The Knowledge And Skills Acquired Can Be Applied And To Upgrade Regularly . I Will Strive By Hardwork To Achieve Highest Responsible Position Along With The Organisation.
EDUCATIONAL QUALIFICATION

Examination Board / University Year of passing Percentage
M.sc. ( Microbiology) North Maharashtra University, Jalgaon
April 2009 65.05 %
B.Sc.( Microbiology) North Maharashtra
University, Jalgaon
April 2007 65.00 %
H.S.C. Nasik Board
Feb 2003 69.33 %
S.S.C. Nasik Board
Feb 2001 76.93 %
WORKING EXPERIENCE
-Working from 1 Year in HAFFKINE BIOPHARMACEUTICAL CORPORATION LTD., Parel, Mumbai a Oral Polio Vaccine Producing (WHO Approved) Company .
-Having experience of QA , QC, and Production of oral polio vaccine departments.
Experience of Quality Assurance Dept.-
-Document Control
-BMR( Batch Manufacturing Record) Scrutiny
-Preparation of SOPs, MF (Master Formula), Site Master File, PSF (Product Summary File)
-Calibration Of Various Instruments :
-pH meter
- Electronic balance
- Thermometer
-Validation of :
- Utility ( Steam, Compressed Air)
- Area( Air Velocity, Filter Intigrity, Air Changes Per Hour ie. ACPH etc.)
- HEPA / LAF
- Autoclave / load patterns
- Cold storage
- Cold chain validation
- Process Validation( Concurrent Validation)
- Media Fill Validation
- Product Change Over
- Cleaning Validation
- Self Audit
- Training Documentation : On job & Classroom
- Validation Master Plan Traing
- Acceptance & Approval Of Oral Polio Vaccine Monovalent Bulk And Vaccine Vial Monitor (VVM) Labels
-Approvals Of Various Raw Materials & Finished Product
Working Experience of Quality Control-
- Sterility By Direct And Membrane Filtration Method Of :
-Inprocess And Final OPV Sample
-Water For Injection
- Raw Materials
- Droppers
- Environmental Monitoring Of Viable Count By :
- Settal Plate
- Air Sampler
- Contact Plate
- Sterile Cotton Swab
- Glove Prints
- Garment Monitoring
- Bacterial Endotoxin Test For Water & Raw Materials
- Microbial Limit Test for Pathogens In water & Raw Materials
- Total Microbial Count Of Water
- Groth Promotion Test Of Media Used In Sterility
- Identification Of Common Contaminants In Aseptic Area
- Isolation & Maintainance Of Standard & Wild Microbial Cultures
-Potency Testing Of Opv Vials By Neutralization Using Type Specific Antisera & Hep2 C Cell Line By Microtiter Plate Method
-Maintenance Of Hep2 C Cell Line By :
- Splitting Of Cells
- Changing Of Medium
- Maintenance Of Hep2 C Cell Line In Liquid Nitrogen
- Antisera Testing
- Preparation Of Reagents Like :
- MEM ( Minimum Essential Medium)
- TPVG ( Trypsin, Versene , Glucose)
- Antibiotics
- Testing Of Cold Chain Monitor Cards
- Stability Testing Of Product OPV At Various Temperatures
- Exposure To FDA Audit.
- General cGMP & GLP Training
Experience of Oral Polio Vaccine Production Dept. –
-Entry & Exit Procedure In Aseptic Area
-Working In Aseptic Area Grade A/B, C, D For Blending ,Filling , Sealing, Visual Inspection, Automatic Labeling & Packaging Of OPV
- Blending of OPV Monovalent Bulk Type 1,2 & 3 With Diluents
-Preparation Of Diluent
- Non Viable Partical Counting For Maintaining Aseptic Area
-Writing Of Batch Manufacturing Record
-Acceptance Of Oral Polio V accine Monovalent Bulk type 1, 2 & 3
-Acceptance Vaccine Vial Monitor (VVM) Labels And Optical Density Taken By Densitometer
Preparation Of Sterile 70 % Isopropanol Solution
-Preparation Of Sterile Disinfectant Solution And Records Thereof
-Estimation Of Inprocess pH And Volume Of OPV
-Maintenance Of Records Of Clean Room And Deep Freeze Area Parameters As Relative Humidity,Temperature, Pressure
-Maintenance Of Consumable Stock Record

TRAINING EXPERIENCE
Training Project related to “Rabies Vaccine Production and Quality Control” done in factory premises of ‘Chiron Behring Vaccines Pvt.Ltd.’ ,Ankleshwar, Gujrat.

FIELD OF TECHNICAL EXPERTISE
1)Molecular Biology-
- Isolation & Purification Of Genomic & Extra Chromosomal Nucleic Acid From Microorganisms From Different Sources.
-Qualitative & Quantitative Estimation Of Nucleic Acid & Protein.(Specrophotometric & Colorimetric Analysis)
-Electrophoresis & Blotting Technique.
2) Genetic Engineering-
- preparation of gene library
- cDNA Synthesis & Cloning
3) Biochemistry-
-Chromatographic Techniques
-Solvent Extraction
-Estimation Of Sugars & Proteins Using Different Chemical Methods
4) Microbiology & Fermentation Technology-
-Isolation, Identification & Characterization Of Microbes From Sources
-Fermentation Production Of Various Products
-Biotransformation
5) Instruments Expertise-
-UV-Visible Spectrophotometer(JASCOV-530)
-PCR Machine(Peltier Thermocycle(PTC-200)MT)
-Cooling Centrifuge(REMI)
-Inverted Microscope(ZEISS)
-co2 incubator(BINDER)
-Autoclave(METELCHEM)
-Laminar Airflow Cabinet(Micro-Filt)
-pH Meter
-Shaker Incubator
MSC PROJECT
“Study of Microbial Interaction in consortium of Banana (Musa Spp.) Rhizosphere.”
-Isolated Cultures Are Found To Be Of Pseudomonas sp. & Assayed For There Physical,Biological & PGPR Properties. Chemotactic Responses Of Isolates Studied Upto Some Extent.They Found To be Exopolysacharide (EPS) Producing, Phosphate Solubilising (PSM) & Indole Acetic Acid Producing (IAA) .

EXTRACURRICULAR ACTIVITIES
-Forth prize in State level Microbiological Contest, 2006. -Participation in Poster Presentation Competition at GeneRations2006, IIT, Pawai.
-Selected for Foundation for Academic Excellence & Access Scholarship, New Delhi.
-Selected as a Coordinator of “SYMBIOSIS” student association, School of life sciences, North Maharashtra University, Jalgaon.
- Worked with team of classmates to organize a national conference on ‘genetically modified crops : statues, issues & awareness.’
-UGC-SAP-DRS seminar on ‘Recent Trends in Agro biotechnology’.
-Certificate Course in Hazard Analysis Critical Control Point.
-National Workshop on ‘Self- Development’organised by Ford Foundation Pathways Project,New Delhi.
-Seminar Delivered On“Gastric Cancer Caused By Helicobacter pylori.”

PERSONAL PROFILE
Date of birth : 28/ 12/ 1985
Gender :
Marital status : Unmarried
Nationality : Indian
Languages known : English, Hindi and Marathi.
The above statements are true to the best of my knowledge and belief.

Ms. Sonali Pandurang Burkule

[786khanarshad]

MOHD ARSHAD
- INFORMATION
- JOB TITLE…………… …………………………………..
- JOB LOCATION………Mumbai …………………………………
- CAREERO OBJECTIVE
- To be in a position in an organization where I will be able to utilize my skills and knowledge. A strong desire and capability to pursue a career in corporate world. My work will reflect my deep conviction to quality and through satisfaction of my superiors.
- ACADEMIC QUALIFICATION
- GRADUATION - BA passed from ALLAHABAD UNIVERSITY(2007)
- SENIOR SECONDARY - 12 passed from U.P.BOARD(2004)
- HIGER SECONDARY - 10 passed from U.P.BOARD (2002)
PROFESSIONAL QUALIFICTION
- MASTER OF BUSINESS ADMINISTRATION (INTERNATIONAL BUSINESS) from INTERNATIONAL BUSINESS SCHOOL (Mumbai)
- ASSIGNMENT PROJECT REPORT - TATA INDICOM & RELIANCE INFOCOME (Special focus on manufacturing division & product)
- INDUSTRIAL TOUR - PARLE G company in vile Parle Mumbai
- TECHNICAL QUALIFICATION
- 6 month DIPLOMA IN COMPUTER SOFTWARE (DCS) from S.IS.I ALLAHABAD(2002)
- 6 month DIPLOMA IN COMPUTER HARDWARE((DCH) from S.IS,I , ALLAHABAD(2003)
- Specialised in NETWORKING
- WORK EXPERIENCE
- Sales trainee in TATA INDICOM from 10 jun 2004 to15 nov 2004 (ALLAHABAD)
Conduct meeting with client provide information about product and services ,which our organization provides.
Deal with corporate client & retail clients .
- Marketing Executive in HCL AND DELL COMPUTER from 5 feb 2006 to 16 sep 2006 (ALLAHABAD)
Direct sale of computer and computer accessories, Installation of operating system, Repair & maintenance of computer hardware and promotion of new products.
- ACHIVEMENT
- Participated in university and others level drama and fashion show program.
- Achieved best person (unique) award in 1st sem a mba.
- Participated in essay writing quiz & science exhibition in school level
-
- PERSONAL INFORMATION
- Date of birth 07-07-1984
- Sex MALE
- Marital status SINGLE
- Fathers name MOHD NAJIB
- Mother name MUMTAZ FATIMA
- Permanent Address : - 219A, CHAK RAGHUNATH, NAINI, ALLAHABAD-211008
- E-mail :- aamikhan.khan9 AT gmail.com , arshad.mosameer AT gmail.com
- Contact Numbers - 09696504943, 08080432722
I confirm that the information provided by me is true to the best of my knowledge and belief.


Date : __________________________
Place : MOHD ARSHAD

[Guest]

RESUME
MR. SUNIL D. GAIKWAD,
‘Omkar’ Building, 2nd Floor, Room No. 15,
Kakartale, A/P. Tal. Mahad, Dist. Raigad, Pin. 402 301,
Email-gaikwadsd1803 AT rediffmail.com
Cell. : 9730029339,9764635820
PERSONAL PROFILE
· Name : Mr. Sunil D. Gaikwad
· Date of Birth : 17th September, 1985
· Languages Known : Marathi, Hindi & English
· Marital Status : Married
· Nationality : Indian
· Permanent Address : A/P. Chikhali, Tal. Shirala, Dist. Sangli,
Pin. 415 408.
ACADEMIC CAREER
Passed B.Sc. (Chemistry) from Shivaji University-Kolhapur in 2008.
COMPUTER AWARENESS
Passed MS-CIT with 1st Class.
WORK EXPERIENCE
· Designation : Chemist
· Period of Service : Since 5th June, 2008
· Name of Employer : M/s. Embio Ltd. E-21, M.I.D.C. Mahad,
Tal. Mahad, Dist. Raigad, Pin. 402 309.
PRODUCT HANDLED
(1) l-Ephedrine HCl
(2) Pseudoephedrine HCl
(3) Pseudoephedrine Sulphate
(4) l-Norephedrine HCl
REASON OF LEAVING
For better prospects
JOB RESPONSIBILITIES
Handling of various instruments as,
· pH Meter - Metteler Toledo
· Melting/Boiling Point App. - Metteler Toledo, Veego
· Digital Polarimeter - Jasco
· Refractometer - Gurunanak Ind.
· FTIR - Shimadzu
· Karl Fischer App. - Mettler
· Potentiometer - Mettler Toledo
· U.V. Spectrophotomer - Shimadzu
· Analytical Sieve Shaker - Restsch
· Humidity Control Oven - Newtronic
· Bulk Density App. - Labshop Equipment Co.
· Analytical Balance - Mettler Toledo
· Gas Chromatography - Shimadzu
- Inprocess & Intermediate Sample Analysis
- Sampling & Analysis of Final Product as per IP/BP/USP/JP
- Preparation & Standardisation Volumetric Solution
- Documentation as per USFDA & Cgmp norms
- Handling Platinum Recovery Section.
ABOUT THE COMPANY
Ephedrine HCl, Pseudoephedrine HCl & it’s derivative in cold & cough range.
The company have it`s Australian TGA, USFDA & Europe Certificate of suitability approved plant.
Familiar with Good Manufacturing Process (GMP)
DECLERATION
The above information furnished by me is true & correct to the best of my knowledge & belief.
Date :
Place : (MR. SUNIL D. GAIKWAD)

[Guest]

Subject : - Application for the suitable post of QC,R&D.
Respected Sir,
I have completed M.Sc.Analytical chemistry from Swami Ramanand Theerth University, Nanded. With first class (74.25%) I wish to apply for the above said post in your organization. I have attached my resume with application. I hope you will consider my application kindly.
RESUME

Mr. Shinde Ravindra Pralhad
Email : shinderavi801 AT gmail.com Mob: 9767272593

OBJECTIVE :
To work with integrity and honesty for the betterment of the company, be a value addition to the company through efficient, innovative and effective work towards achievement of organizational goals and to grow in character within the company
DETAILED KNOWLEDGE :
Chromatographic techniques such as Paper, Ion Exchange, HPLC, GC, TLC,etc.
-Spectroscopic Methods (UV, IR,MASS,NMR)
-Analytical Chemistry,
Colorimetric,Potentiometric,Conductometric,Volumetric,Gravimetric, instruments are handled and experiments are performed.
CORE SKILLS AND ACTIVITIES :
· Ability to work in team with good co-ordination and co-operation.
· Sound knowledge of methods of synthetic chemistry.
· Hard work and result oriented.
Educational Qualifications :
Sr.No. Qulified Exam University/board Subjects Year of Passing % of marks obtained Class obtained
1 . M.Sc. S.R.T.M.U.Nanded Analytical Chemistry July 2011 74.25% First Class
2. B.Sc. Shivaji University, Kolhapur Chemistry oct 2008 60.05% First Class
3. H.S.C. KOLHAPUR Languages Phy. Chem. Bio. Feb. 2005 48.83% Second Class
4. S.S.C. KOLHAPUR Languages social sci., science,&Maths. Feb. 2003 53.54% Second Class

M.Sc. PROJECT WORK :
Project Work on “Synthesis of 1,8 diixo-octahydroxanthene derivative.”

[Guest]

CURRICULIM VITAE
Mahesh C. Patil
Email - mahesh_cpatil AT rediffmail.com
maheshcpatil73 AT gmail.com
Career Objective
To excel in the field of Quality assurance/Quality control of Pharma.
Professional Qualification
B.Sc. (chemistry), 2nd class, from North Maharashtra University, Jalgaon in 1998.
Professional Experience
[Total 12year : In Quality Assurance / Quality control Department ]
Since May 1999 working with Emcure Pharmaceutical limited, as Executive Quality control Department.
Current Job Profile
Calibration of all instrument HPLC, GC, FTIR, UV/VIS Spectrophotometer and Auto Dissolution tester, and Disintigration Apparatus etc
Analytical method validation for drug products for Assay and Dissolution.
Analytical Process validation.
Specification preparation and SOP preparation.
Checking, updation, revision and issuance of, specifications, standard operating procedures, for regulated and less emerging market.
Preparation of stability study protocol, cleaning validation protocol and setting of acceptance limits of cleaning validation and planning if stability study.
Row material, in process sample analysis and finished product analysis on HPLC
and GC.
Stability study as per ICH guidelines.
Preparation of Calibration procedures and validation documents (IQ, OQ and PQ) for Analytical instruments.
Preparation of site master file, master validation plan and preparation of process validation protocol.
Handling of OOS, OOE ,Change control & Deviation related to manufacturing and analytical documents.
Knowledge of Regulatory related work
Major achievements :
Team member for approval of ISO 9002.
Maharashtra FDA approval in chemical and instrumentation.
Instruments Handled
All Analytical instruments handled e.g. HPLC (TSP, SHIMADZU, JASCO make)
, GC , KF Apparatus, FTIR , UV/VIS Spectrophotometer and Auto Dissolution tester, and Auto Titration Apparatus etc.
Computer Skill :
SAP System
Operating system: MS-DOS, Windows 2007.

[jnawaz876@gmail.com]

Jahangir Ishaque Mulla
Father name : Ishaque Ali Mulla
Nationality : Indian
Date of birth : 22/11/1998
Postal address : Yashwant nagar,
Shill phata khopoli,
Tal khalapur,
District - Raigadh
Marital status : single
Contact number : 8552878241

QUALIFICATION :
** SSC passed
** HSC Science
** Basic computer knowledge

LANGUAGES KNOWN :
** ENGLISH
** HINDI
** MARATHI
** URDU
** BENGALI

EXPERIENCE :
5 month experience in Airtel Customer Care service in Tata Business support service in Khopoli.