Validation Lead Resume Chicago, IL - Hire IT People

SUMMARY:

7 to 10 minimum years of experience in the Pharmaceutical industry.
Excellent verbal and written communication skills, Customer Service Focused; Information Technology background, experience within a Quality/Regulated environment including SDLC.
Strong interpersonal and technical writing skills and the ability to interact across divisional boundaries.
Ability to manage multiple tasks and projects simultaneously, and to prioritize work, goals and tasks per the divisional and corporate objectives.
Ability to report results clearly and concisely. Sound reasoning and ability to quickly analyze and solve complex problems.
Significant Work Activities & Conditions Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Experience with Quality Center (HP Quality Center) preferred.

PROFESSIONAL EXPERIENCE:

Validation Lead

Confidential, Chicago, IL

Responsibilities:

Lead/support validation efforts and deliverables for systems used for Discovery/Development Sciences/Instruments/Clinical/Pre - clinical with minimal oversight.
Develop the validation testing strategy for large and medium sized projects and develop the overall Validation plans and timetables.
Create and execute Review and Trace validation test scripts and documented test results, in accordance with company standards, to verify full test coverage, based on VRB Approved Validation Strategy, and acceptable results.
Review and evaluate validation assessments for application systems/projects.
Ensures that validation project documentation is in compliance with company policies and procedures
Prior Experience with validation of Discovery/Development Sciences/instruments/Clinical systems preferred.
Require prior experience in creating Change Requests, Developing Validation Plan, test scripts, Summary Reports, Traceability Matrix and other validation project documents in the Pharmaceutical industry preferred.
Create and execute validation test scripts and document test results in accordance with standards (Manually or in Quality Center)
File validation documentation within following Quality Assurance Library guidelines.
Ensures that project documentation is in compliance with AbbVie s policies and procedures
Provide regular status reports on of validation activities in the organization to Validation SME, PM and/or Validation or IT Manager, as requested.