Validation Lead Analyst

Location: Chicago, IL
Date Posted: 06-15-2016
Our client is looking for below Job opportunity.
 
Title: Validation Lead
Duration: 6 Months
Location: Chicago IL
 
Job Description:
1.            Leads the Computer Validation activities within a project with medium to high complexity.
2.            Responsible for creating, managing, and/or maintaining the documents required for the development and validation of the computerized system.
a)            Create and review all validation documents in the project.
             Authors Validation Plan, Training Plan, Issues Log, Design Review, IQ Protocol/Report, OQ Protocol/Report, PQ Protocol/Report, Test Cases, Test Incidents, Trace Matrix, and Validation report.
             Reviews Functional Specifications, Design Specifications, User Manuals, System Procedures, System Description and Training records.
b)            Creates or contributes to the Supplier Audit Report, if required.
c)            Contributes to or gathers CSV metrics for reporting purposes.
3.            Oversight of protocol execution
a)            Manages the overall protocol execution process, including resource management, scheduling/timeline management, incident management, and status reporting.
4.            Prepares documentation within a validation package per policy and procedure to support the validation of an application/system.
5.            May participate in the development of internal CSV training materials.
6.            May indirectly manage Validation Analysts activities within a project.
7.            Leads or participates in CSV effectiveness and improvement initiatives.
8.            Leads or participates in CSV knowledge development.
9.            Co-ordinate between various sites for validation of Global Labeling Platform
10.          Devise Master Validation Plan in collaboration with all the responsible project teams including documentation  of the scope, detailed time estimation, work schedule and the documentation of assumptions and risks
11.          Work with respective teams to determine regulatory requirements, validation requirements, business & functional risks and ensure documentation of the same
12.          Design templates and checklists to monitor the progress of the project and ensure that all the required information is captured and documented
13.          Responsible for URS, FRS, Risk Assessment, IQ/OQ/PQ Testing and Validation Summary Reports.
14.          Follow up with SMEs and stakeholders to ensure timely inputs and approval
15.          Responsible for accuracy of work.
16.          Excellent oral and written communication skills
 
 
 
EDUCATION and Experience
 
•             Bachelor’s degree in Computer Science with 8-10 years of experience in validating software systems in an FDA, GxP regulated environment.
•             Experience in Life sciences or Pharmaceuticals processes / projects especially in Product Content / Labeling is preferable.
 
 


At least a bachelor’s degree in Computer Science, Engineering or related field or an equivalent in education is required for this position.
We are an Equal Opportunity Employer.
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