Saturday, June 26, 2010

[itroundtable] LEAD: Validation Cnsltnt - NJ - 6 mos contract

 

My name is Asim. I am an Executive- Intellectual Capital Development with Caresoft Inc. Our Team has been assisting the Client - on one of  their critical Project
 

Tittle Validation Consultant

Location  Hopewell, NJ

Duration 6 Months+

 

Skillls

  • Apply FDA, MHRA, and other applicable global regulations to the development of computer systems supporting regulated business processes
  • Follow SOPs and industry best practices
  • Conduct training on good documentation and good testing practices
  • Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system
  • Review validation deliverables for projects which are contracted to third party suppliers
  • Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation,
  • project validation status, and other relevant issues
  • Assist in planning, implementing, and documenting user acceptance testing
  • Review computerized systems validation documents such as:
  • Requirements Specification
  • Design Specification
  • CSV Risk Assessment
  • Test Plans
  • Test Summary Reports
  • Data Migration Plan
  • Pre/Post Executed Test Scripts
  • Traceability Matrix
  • Release to Production Statements
  • Direct and review testing
  • Provide guidance on quality issues that affect the integrity of the data or the system
  • Prepare validation summary and test summary reports
  • Obtain and respond to QA review
  • Participate in establishing standard quality and validation practices
  • Independently assess compliance practices and recommend corrective actions
  • Approve validated computer system related change requests
  • Monitor regulatory and inspection trends and advise the business on suitable action
  • Clinical system exceperince is must. 
If you feel, this position will be a right step in your career path, please send me a copy of your resume (preferably in Word format).
 
Please reply with Following Details:
Full Name:
Availability for new project:
Current Location:
Willing to relocate:
Expected Rates:
Best time to call & Contact No.:
Work Status ( Citizen / Green Card/ EAD/TN/ H1B):
Employer Details :
(Employer  Name,  E-mail ID, Contact No., Company Name)

 

Thanks & Regards,
 
Asim Taj,
Executive - Intellectual Capital Development
Caresoft Inc.  220 Lincoln Blvd., Suite 300, Middlesex, NJ 08846   URL :
http://www.caresoftinc.com/
Phone 732-993-6258     Fax : 732-875-0595     eMail:
ataj@caresoftinc.com
*** Among


MIS Ntwk Assoc Mtg Dates:

June 29th - Recruiter Night Out Dinner mtg - Joe Gadino CSC Moderator - Diane Briggs KPMG - Mike Petronaci JHeart - John McKinley Morotta Controls - Janelle Razzino Razzino Associates
July 6th - No Meeting Holiday
July 13th - Tues - Bring 20 copies of your resume - 6 pm - NEW LOCATION - BERMAN LARSON KANE (BLK) 12 Route 17 North, Suite 209 Paramus, New Jersey 07652 - Do not use GPS - go to BLK site for directions - 201.909.0906 - plan to have dinner with us afterwards

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