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, *** 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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