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REQ: Validation Analyst at Bridgewater, NJ

Skills: Validation Analyst
Location: Bridgewater, NJ
Duration: 6 Months
Interview: Telephonic
 
Job Description:
Description:
•            Apply FDA and other applicable global health authority regulations to the development a competency in IT for computer systems supporting regulated business processes.
•            Develop SOPs
 
o            Requirements Specification
o            Design Specification
o            CSV Risk Assessment
o            Test Plans
o            Test Summary Reports
o            Data Migration Plan
o            Pre/Post Executed Test Scripts
o            Traceability Matrix
o            Release to Production Statements
•            Partner with QA
•            Familiar with regulatory and inspection trends and advise the business on suitable action.
•            Ability to create documents to an existing document standard.
•            Able to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries.
 
Thanks,
Ezaz Ghanchi
cyberThink Inc.
Bridgewater, NJ 08807-1774
Primary: 908-739-3786
Secondary: 908-396-7105
 
Connecting with the best and brightest is our goal, please ask about our referral bonus policy.
cyberThink Inc. is an Equal Opportunity Employer.
 
 

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