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Validation Project Support Specialist - Madison, United States - Ichgcp
Description
**Validation Project Support Specialist**
**Laboratory Corporation of America Holdings (Covance)**
****Madison, Wisconsin, United States****
**Job Overview:**
Covanceby Labcorp is recruiting a Validation Project Support Specialist for a dynamic team, based in multiple locations. Get ready to redefine whats possible and discover your extraordinary potential at Covance. Here, youll have the opportunity to personally advance healthcare and make a difference in peoples lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, youll be empowered to own your career journey with mentoring, training and personalized development planning.
Reporting to the ED Global Manager, Computer Systems Validation, the Validation Documentation Support Specialist I is primarily accountable for authoring computer system life cycle documentation in conjunction with the business and any other applicable support functions, as well as collecting the documentation for creating and maintaining electronic copies and archiving paper originals. This position will provide guidance and/or authorship for software validation documentation, periodic review documentation, and any other computer system life cycle documentation as needed for the Early Development and Chemistry Solutions business units and will liaise with IT Project Managers, business unit resources and business unit leadership to gather the necessary information to complete the assigned documentation.
**Essential Job Duties:**
**Validation Strategy**
Assist with establishing, reviewing, executing, and ensuring compliance with governmental regulatory requirements, policies, standards, and procedures related to processes for CSV and qualification of infrastructure components.
Assist with the implementation of a common System Development Life Cycle (SDLC).
Advise the project team on and be responsible for CSV strategy and documentation of product functionality across system releases.
Coordinate project-specific CSV efforts, including coordination of the execution of the test plan.
Recommend proper controls for the Covance's computer systems to ensure the reliability of applications and infrastructure, as well as the integrity of data and safety of subjects.
Utilize tools for conducting and executing CSV.
**Testing**
Provide direction to assure that applications and infrastructure components possess the necessary level of testing, and required documentation to comply with applicable GxP regulations and client requirements/expectations.
Ensure compliance with Covance standard testing methodologies, procedures, and practices.
Prepare validation and test strategies for IT initiatives, and present to project teams.
Work with Project teams to identify test requirements and advise on the design of testing phases, as well as documentation of test plans & test case specifications to meet system needs.
Advise on/be involved in the performance of application, functional, usability, performance load-stress, & user acceptance tests.
Ensure that the testing is completed on time and that it addresses all user and functional requirements as defined during the requirement definition process.
Perform documentation reviews and conduct analyses of validation process issues and testing results.
Ensure that software faults are identified and documented, and coordinate with development staff so that testing issues are isolated and resolved.
Ensure that all necessary project-specific CSV documentation is produced, and for reviewing the material for correctness, completeness, and clarity.
**Partnerships**
Liaise with the IT QC function to develop and implement a continuous improvement model of the Covances validation methodology and SDLC.
Periodically conduct training for staff and business associates as to their respective responsibilities within the validation methodology
**Education/Qualifications:**
**Minimum Required:**
4+ years experience in a FDA (GXP) regulated industry (i.e. such as pharmaceutical, medical device, or biotechnology)
Bachelors Degree or higher preferred (ex. science based, operations research, technology, etc.)
Industry related certifications preferred (e.g. PMP, CQE, CQM, etc.)
**Experience:**
**Minimum Required:**
1+ years experience in execution of projects, experience in partnering with/guiding internal clients to deliver on project goals
Familiar with various validation methodologies (SDLC), and their implementation in an IT organization
Knowledgeable of regulatory compliance requirements in the pharmaceutical and drug development industry (GXPs)
Implementing and maintaining risk-based validation model & strategies
Creative approach to resolving technical issues, and balancing business needs
Program & Project Management experience ability to plan, organize, and execute work across multiple initiatives to drive delivery of validation commitments
Ability to coordinate strong teams, and manage multiple priorities
Demonstrates self motivation to lead teams on a unified validation strategy, while achieving department goals, objectives, and initiatives
Exceptional verbal, written, presentation, interpersonal skills, and ability to command respect of others
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