RESUME
Career Objective
To associate myself with an organization that provides me an opportunity to show my skills and ability, improve my knowledge and to be a part of the team that works dynamically towards the growth of the organization.
Experience
* From:22nd January 2008 to Till date –Otsuka Chemical India limited. (Japanese Group)
Keswana Rajput, Baharor, Rajasthan
Position: Executive Quality Assurance/Quality Control
* From: April 2004 to 13th January 2008 – Ranbaxy Laboratories Limited, Toansa. Position: Quality Control Officer
* From 20th October 2003 to 15th march 2004 in Windlas Biotec Limited Dehradun.
Position: Quality Control Chemist
Job responsibilities:
Quality Assurance
v Preparation of Quality System.
v Preparation of SOP’s STP’s SCP’s and general Working Instructions.
v Preparation of Qualification program for all Instruments.
v Design Qualification for new instruments
v Preparation of Vendor Assessment Program.
v Vendor Approval.
v Preparation and implementation of Analyst Validation Program.
v Ensuring the documentation as per ISO and FDA requirement.
v Preparation and implementation of System, User and Backup/Archival Guidelines for all instruments using in Quality Control as per 21CFR Part11.
v Data Review (Protocols, Instrument calibration and usage Records, Daily and Monthly Backup Of Instrument).
v Handling of Planned and Unplanned deviation.
v Investigation of OOS.
v Handling of Vendor Samples.
v Internal and Customer Audits to meet cGMP.
v Preparation of AMC and PM Programs for instruments.
Quality Control:
v Monthly backup and Archival of Computer System associated with Quality Control Equipments.
v New Instruments Qualification (IQ, OQ, PQ)
v Knowledge of SAP, BAAN DMS and DCS Software in Quality Module.
v AMC and Preventive Maintenance Record Maintenance.
v Planning Of Manpower.
v Chemical Inventory.
v Testing of Dosage forms, API, Raw materials, Intermediates and In-Process Samples
v GMP/GLP compliance in the respective areas, of Quality Control Department.
Instrumental Skills
v HPLC (Waters With Millennium 2000& EMPower)
(Shimadzu with LC Solutions)
v UV Spectrophotometer (UV 3310 Hitachi)
(Shimadzu 1700 with UV Probe)
v Atomic Absorption Spectroscopy. ( Perkin Almer 3100)
v Gas Chromatography. ( Perkin Almier with Chemstation)
( Agilent Technology with Chemstation and Chemstore)
v NIR Spectrophotometer (Foss).
v FTIR – (Perkin Elmer Spectrum One)
(Shimadzu 8400S with IR Solutions)
v Polarimeter (Autopol)
v HPTLC – CAMAG
v Auto Titrator – Metrohm, Mettler and Orion.
v DR & DT Apparatus.
v Flame Photometer
v Thermal gravimetric Analysis.
Accomplishments
v Involved in the laboratory setup.
v OOS and OOT investigations.
v Change control System (Planned/ Unplanned)
Academic Qualification
v Post Graduation Specilization in organic Chemistry
v Graduation Specilization in Industrial Chemistry
Research Experience
v One moth project work on manufacturing of tablets and Syrups.
v One month project work on manufacturing of large volume parental.
Audit Faced
F Successful completion of US FDA, ISO European and Customer
Audits.
Personal Profile
Name : Vivek Vashistha
Father Name : Shr. Mahesh Kumar Sharma
Date of Birth : 06/09/1981
Marital Status : Married
Nationality : Indian
Gender : Male
Languages Known : Hindi and English
Hobbies : Listening Music, Natural disaster Movies,
Permanent Address : Vivek Vashistha
S/O Mr. Mahesh Kumar Sharma
H. No. 8/1256
Pratap Nagar Saharanpur
247001 (UP)
Salary Status :
Current CTC : 3.2 Lac pa.
Expected CTC : 3.8 Lac pa.
References :
Dr. A.K. Dubey Mr. K. K. Sharma
Manager QA/QC Sr. Manager
Otsuka Chemical India limited Shriram automotive Products ltd.
Keswana Rajput Baharor Connaught Place
Rajasthan New Delhi
dranandkdubey@yahoo.com sappl1@vsnl.com
I M working in Otsuka Chemical india limited as a Executive QA/QC having almost 5 year experience in pharma sector and worked in some reputed companies like Ranbaxy (india) 
