| CSV Engineer at Remote, Remote, USA |
| Email: [email protected] |
| From: Ammy, Resource Logistics [email protected] Reply to: [email protected] New Billing, Exclusive, CommittedComputer System ValidationValidating systems used in R&D/Clinical and PLM pillars Validating Data migration project. Experience in the Pharmaceutical, industry 8+ years experience with System Development Lifecyle Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. in Clinical SpaceKnowledge of FDA guidance s and industry standards (i.e., GAMP) Experience in writing and executing documentation for all aspects of the validation deliverables like Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs. Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures. Strong verbal and written communication skills. Ability to work as a team player, lead a team or accomplish tasks without supervision. Ability to work with remote teams and support several changes/projects simultaneously. Ability to provide Validation guidance, timely reviews, and escalations to Techolongy Quality management. (1.) To architect, design and develop (through Team) solution for productorproject and sustenance delivery (2.) To support as an SME (3.) To ensure knowledge up-gradation and work with new technologies so that the solution is current and meets quality standards and the client requirements (4.) To train and develop team so as to ensure that there is an adequate supply of trained manpower in the said technology and deliver risks are mitigated (5.) To gather specifications and deliver solutions to the client organization based on understanding of a domain or technology (6.) To review project deliverables. (7.) To recommend client value creation initiatives and implement industry best practices (on specific technologyorproduct) Keywords: quality analyst rlang CSV Engineer [email protected] |
| [email protected] View all |
| Wed Aug 21 04:50:00 UTC 2024 |