Hi Friends,
Greetings,

 

Please find below requirements and kindly send me suitable profiles along with 
the contact details ASAP.

Please send updated resume with Rate confirmation only to [EMAIL PROTECTED]


Telephonic + F2F>>>>> preferred locals

 

Position: Sr Validation Consultant

Location: Summit, NJ    

Duration: 4-6 Months

Rate: $BEST RATE

 

Description:

Performs consistent validation and process excellence on assigned  projects 
while demonstrating in-depth knowledge of computer system validation (CSV), 
equipment qualification and health authority regulations.

  a.. Applies strong knowledge of computer system validation across all 
technology types, including application of system lifecycle methodologies and 
documentation requirements. 
  b.. Works independently and within a team, under the guidance of the 
Validation Unit, on CSV projects and provides guidance on validation concepts 
with minimal oversight. 
  c.. Develops validation deliverables for computer system related projects, 
including: 
  d.. System Validation Plan, Requirements Specification, Traceability Matrix, 
UAT Test Plan, Validation Summary Report 
  e.. Works collaboratively with other key stakeholders to prepare system 
regulatory and risk assessments. 
  f.. Leads the creation of computer system procedures such as System Use, 
Change Control, Problem Reporting, Configuration Management, Performance 
Monitoring, Business Continuity, etc. 
  g.. Prepares and executes computer system validation strategies associated 
with Change Controls activities. 
  - Performs Periodic Reviews on regulated production computer systems. 
  h.. Supports validation unit in determining remediation strategies when 
automated and/or computer system require remediation. 
  i.. Demonstrates proficiency in applying Health Authority regulations as well 
as global and local guidelines, SOPs and procedures. 
  j.. Reviews SOPs related to validation to ensure compliance within assigned 
project activities. 
  k.. Develops program training as required for either classroom or automated 
delivery (e.g. VLC standard and CSV requirements). 
  l.. Provides classroom training to client population as required to meet 
program or standard objectives. 
  m.. Assists in establishing business requirements by studying and 
understanding assigned business procedures and processes. 
 


 

 



Brad Young
Data Group Inc
Website: www.datagroupinc.net
Certified Minority Women Owned Business Enterprise (MWBE) & Small Business 
Enterprise (SBE) 
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