Computer Systems Validation Consultant

San Francisco  ‐ Onsite
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Keywords

Description

The Computer Systems Validation Analyst - Contractor will be responsible for validating computer systems to ensure compliance with relevant regulations such as 21 CFR Part 11, Annex 11, and cGMPs.

Essential duties include, but are not limited to the following:


  • Validation activities for computer system implementation projects (SAS, EDMS & others)


  • Collaborate across functions with IT, Business, Vendors, and Consultants to plan, coordinate, and execute computer system validation activities


  • Author requirements for computer systems to ensure compliance with regulations such as 21 CFR Part 11, Annex 11, and cGMPs


  • Perform and lead risk assessment exercises in support of computer system validation


  • Author validation documents such as Validation Plans, Test Plans, Deviations, and Summary Reports


  • Oversee user testing and ensure validation testing is conducted in an appropriate and timely manner


  • Analyze and summarize validation results


  • Work collaboratively with Quality Management to support improving computer system validation processes and practices


  • Assist with training around computer system validation, quality practices and/or applicable regulations as needed.


  • Participate in the change control process


Requirements:


  • Direct hands-on experience validating GxP Computer Systems


  • 5 -7 years related experience in cGMP/FDA regulated industry.


  • Familiarity with GMP and other approaches to System Development Life Cycles (SDLC), GAMP


  • Generally IT knowledgeable and excellent problem solving skills


  • Good oral and written communications skill


  • Able to work independently


  • Strong knowledge of 21CRF Part 11, Annex 11 and cGMPs


Education:


  • Bachelor's degree in computer science, technical discipline or equivalent


To find out more about Real please visit www.realstaffing.com
Start date
04/2013
Duration
12 months
From
Real Staffing
Published at
23.04.2013
Project ID:
525306
Contract type
Freelance
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