Computer Systems Validation Specialist, 100% remote contract

I am looking for a Computer Systems Validation Specialist. 100% remote position. Must have LinkedIn profile.

• This individual?will be assisting with SAP initiatives, so SAP experience will be required, also will be working with GxP assessments
• Definitely?looking for someone with solid SQA experience
• Someone who can write validation plans/reports, follow procedures, self-starter, drive the full process, multitasker (will work on multiple projects at once) - Very hands on
• ALM experience

Looking for a Computer Systems Validation (CSV) Specialist

The CSV Specialist will be responsible for working with functions throughout the organization to successfully carry out the computer system validation strategy through a risk-based approach that ensures the quality and integrity of data over the entire system lifecycle.?

• Ensure that the quality system elements necessary to achieve and maintain compliance across multiple businesses and varied regulatory requirements, are established and activities related to computer systems/software testing are controlled via these elements
• Author, review and/or approve validation plans, protocols, and reports.
• Ensure that test cases are documented and executed following the requirements set forth by procedures and external requirements
• Work with appropriate teams to establish quality expectations related to software quality assurance and computer system validation
• Collaborate with stakeholders in the preparation of software and hardware specification documents and test plans
• Author, review and/or approve system change, configuration management, and supporting documentation activities
• Participate in external/internal computer system/software audits
• Support defect resolution
• Support and monitor the qualification of Information Technology Infrastructure Platforms

Requirements

• Minimum 5 years of experience in a computer system validation role in the medical device, pharmaceutical, biotech, or other regulated industry
• Demonstrated experience in software quality assurance processes, SDLC methodology, supplier quality management, change management, documentation, verification, periodic review, and validation techniques
• Previous SAP experience
• Understanding of current software quality-assurance techniques and software industry standards and their impact on internal procedures, and software quality
• Demonstrated ability to author validation protocols and manage deviations
• Excellent written and oral communication skills
• Highly motivated EMAIL ME if interested: [email protected]