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geeta@pinnacletek.net wrote:
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                                   Geeta Chauhan,
                                   Pinnacletek LLC                                            
       geeta@pinnacletek.net
       Reply to: geeta@pinnacletek.net

Position: Software Validation Specialist

Duration: 6+ Months: Contract

Work Location: Oakbrook, IL - 100% remote opportunity

Start Date: ASAP

Visas: No H1B

Process: Phone Interview > Skype Interview > Hire

POSITION SUMMARY:

The Software Validation Specialist analyzes system solutions and reviews validation protocols, reports, and other Software Development Life Cycle documentation. The Software Validation Specialist participates in the delivery of Software system solutions by assuring validation activities are conducted in a compliant and timely manner. The Software Validation Specialist works closely with other groups to assure the total software solution delivered meets compliance requirements and expectations.

REQUIREMENTS:

BS Degree or equivalent experience. 
Must have strong Validation experience.
Must have strong Software Change Control experience.
Must have strong SDLC management knowledge.
Prepares Software Validation work instructions and manages this work instruction system.
Assists Software Process and System Owners (PO and SO) to plan and manage validation projects
Drafts validation protocols and protocol amendments in compliance with SOPs and work instructions.
Partners and communicates effectively with business customers, IT groups, management, QA, and external vendors to validate system solutions addressing compliance with SOPs, work instructions and validation protocols.
Plans, coordinates, resources for, and manages user acceptance testing.
Performs pre- and post-execution QC checks of user acceptance test scripts and works with SO, IT, and within QA to resolve problems.
Drafts validation final reports summarizing validation activities in compliance with SOPs and work instructions.
Manages the documentation archive (paper-based and electronic) in an inspection-ready state.
Provides guidance to the System Owner, IT, and project organization regarding appropriate documentation practices and methods including creation of documentation and corrections to existing documentation.
Maintains training materials and trains involved groups on software documentation and testing best practices, test coordination, and other topics as needed.

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