*Please submit resumes to sri...@saperedata.com <sri...@saperedata.com>*
Title: Validation Lead with Documentum, SPL and Publisher
Location: Chicago, IL
Duration: 6+ months
*Validation Lead having knowledge of Documentum, SPL and Publisher.*
This position is accountable for contributions to the quality of
project delivery by performing project-applicable Quality Compliance
functions in a global environment, and ensuring that the product
developed meets the requirements defined.
The Regional QSR is responsible for monitoring compliance to the CQPs,
Baxter QMS, and other established IT policies/procedures throughout a
This position will contribute to improving systems/applications
quality by appropriately monitoring processes and providing
recommendations for improvement opportunities for any given region of
1. Responsible for assuring a system/application meets its
requirements and is compliant with applicable Baxter QMS documents,
and the documentation set outlined in the Validation Plan for the
2. Responsible for approving the documents required for the
development and validation of the computerized system.
a. Approves the Validation Plan, Training Plan, Training Records,
Issues Log, Functional Specification, Design Specification, Design
Review, User Manuals, System Procedures, IQ Protocols/Reports, OQ
Protocols/Reports, PQ Protocols/Reports, Test Cases, Test Incidents,
Trace Matrix, System Description, Supplier Audit Report,
and Validation Report.
b. Contributes to or gathers Quality/Risk metrics for reporting purposes.
c. Utilizes HP QC for end to end test management.
3. Supports a CSO in all GxP regulations, compliance with internal
and external procedures, and all aspects of safe, reliable, and
consistent operation of the computerized system. Also considers
non-quality aspects of risk management.
a. Complexity – Performs all complexity work activities that champion
approved IT validation strategies throughout the functions/regions.
Work involves risk-based application of validation approach, and
can include multiple projects/systems work simultaneously.
4. May provide direct or indirect leadership to others.
a. Guide, mentor and motivate team members to think more broadly
related to cross-functional/business risk management.
Provide formal performance review feedback for team resources.
5. CAPA Processesa.
May be responsible for reviewing and approving that all documentation
within a CAPA has met the procedural requirements and CAPA plans.
6. Exception Managementa.
Monitors and reviews exception reports for progress and completeness
against procedural requirements.
7. Ability to manage/influence in a globally matrixed environment
(Community of Practice)
a. Build and maintain relationships across functions throughout a region.
8. Quality Awarenessa. Responsible for understanding and communicating
Baxter’s Quality Management System structure and process.
b. Perform as a champion of QMS processes, initiatives and
improvements throughout a region.
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