Validation Lead Role , Round Lake, IL
Date: Thu, 19 Aug 2010 11:08:46 -0700 (PDT)
Message-ID: <5a34250d-64b9-416b-935e-5d6d6f695e8b_at_s17g2000prh.googlegroups.com>
Title:- Validation Lead Role
Location: Round Lake, IL
Duration: 3 Months +
Position Overview:
This position is responsible for leading and performing activities in
support of the validation and compliance of a system or application.
The Validation Lead is responsible for monitoring compliance to the
CQPs, Baxter QMS, and other established IT policies/procedures.
1. Leads the Computer Validation activities for LAB Tools within a
project or multiple global projects 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. i. 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. ii. Reviews Functional Specifications, Design Specifications, User Manuals, System Procedures, System Description and Training records.
b. Participates in Supplier selection process, if required. c. Creates or contributes to the Supplier Audit Report, if required. d. Contributes to or gathers CSV metrics for reporting purposes. 3. Oversight of protocol execution a. Manages the overall protocol execution process, including resourcemanagement, 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 / Testing activities within a project.
7. Leads or participates in CSV effectiveness and improvement initiatives.
8. Leads or participates in CSV knowledge development.
Desired skills / certifications / training 1. Minimum of 7-9 years experience in Computer Systems or Software Validation – with special emphasis and experience on LAB Tools.
2. Strong knowledge of project development/implementation processes. 3. Ability to make good judgments and quick decisions. 4. Solid presentation skills. 5. Solid oral and written communication skills and teamwork skills. 6. Strong influencing/negotiation skills.
Please send you updated resume to jobs_at_mapleresource.net Received on Thu Aug 19 2010 - 20:08:46 CEST