Role and Responsibilities: Possess hands-on experience with the Veeva Vault Quality Docs System. Develop Computer System Validation (CSV) deliverables including Validation Plan, Validation Protocols (IQ, OQ, PQ), Validation Summary Report, Data Migration Plan and Trace Matrice. Conduct GxP Risk Assessments on computer applications utilized in regulated environments. Perform system assessments in compliance with 21 CFR Part 11 and Annex 11 regulations. Collaborate with Business Users, System Owne
Job Description When you're part of the team at Thermo Fisher Scientific, you'll do meaningful work, that makes a positive impact on a global scale! Join over 100,000 colleagues who bring our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. You'll find the resources here to achieve your career goals and help take science a step beyond by developing solutions for some of the world's toughest challenges. This includes protecting the environm
IT Compliance Specialist Job Summary: The IT Compliance Specialist will be responsible for ensuring our company adheres to legal standards and in-house policies related to information technology operations and security. This role involves assessing and monitoring our IT infrastructure, applications, and operations against regulatory requirements and compliance standards pertinent to the pharmaceutical industry, including HIPAA, HITECH, FDA 21 CFR Part 11, GDPR, and others. The successful candid
Hi , Greetings from Securekloud, We do have opening for our client, Role : Computer System Validation Specialist Location : Remote (EST Timings) Duration : Long-Term Contract Job Description : Role and Responsibilities: Possess hands-on experience with the Veeva Vault Quality Docs System.Develop Computer System Validation (CSV) deliverables including Validation Plan, Validation Protocols (IQ, OQ, PQ), Validation Summary Report, Data Migration Plan and Trace Matrice.Conduct GxP Risk Assessment