Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments Test planning and strategy creation and execution of test protocols, scripts and reports. Validation Summary Reports, traceability analysis. Defect Logging and Tracking till closure. Develop, approve, and execute validation deliverables for computerized systems, including validation plans, risk assessments, and traceability matrices. Author and update documentation to support ongoing CSV compliance. Prepare or review all levels of validation documents including Validation (Strategy) Plans, User Requirement Specifications. Definition Documents, including Functional Specifications S/W Design Specifications or Configuration Documents and SOPs. Qualification Documents and Test Specifications (IQ, OQ, PQ) Traceability Matrices, Risk Analysis. Validation Reports, Change Controls/ Events / Deviations etc. Assess the impact of changes proposed to computerized systems and the level of change required. Provide validation strategy to the introduction of computerized systems. Collaborate with the key stakeholders (Information Systems, Software assurance, business users and suppliers etc.) and management on all related matters on a regular basis. Katalyst Healthcares and Life Sciences
...Hillsboro Aviations contract & charter division provides services to the United States Forest Service (USFS), the Department of Interior... ..., Bell 407HP, and Airbus AS350B3e. As an AS350 Fire/Utility Pilot, you will work closely with the Contract & Charter team to...
...DMV Title Registration Clerk The Title Clerk performs a wide range of administrative and office support duties associated with vehicle documentation, such as taxes, titles, registrations, license plates, and other legal transfer documents regarding vehicle sales or...
Flik Hospitality Group We are hiring immediately for a full time COOK position.Location : Humana Waterside - 101 E Main Street, Louisville, KY 40202 Note: online applications accepted only.Schedule : Full time schedule. Monday - Friday, 6:00 am - 2:30 pm. More details...
...QAPI Coordinator under the direction of Hospice management is responsible for implementing an on-going, comprehensive, integrated, quality performance improvement program. This program is patient-centered, data driven and outcome-based which meets the CMS requirements....
...Food People! Ready to build a career with a company thats leading the food service industry? We Help You Make It! Our Diesel Mechanics start at $33.00 $45.00/hour depending on experience!~401K with 2% automatic company contribution plus company match up to...