Job
Description
Company Description Welcome to AmpleLogic! We're a trusted provider of GAMP solutions, specializing in empowering the life sciences industry through our advanced Application Platform as a Service (aPaaS) platform. We are seeking a highly skilled and detail-oriented Quality Assurance (QA) Specialist with extensive experience in Computer System Validation (CSV) to join our team. This role will focus on ensuring the highest level of compliance, quality, and performance for all software and systems used within our organization, especially those that are regulated under industry standards. The ideal candidate will have a deep understanding of CSV processes, as well as experience working in highly regulated environments like pharmaceuticals, healthcare, or manufacturing. Oversee and execute Computer System Validation (CSV) for software and hardware systems, ensuring compliance with GxP, 21 CFR Part 11, FDA guidelines, and industry standards. Develop, review, and approve essential validation documents such as Validation Plans, URS, FRS, DS, and other relevant documentation. Create, execute, and document IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification) test protocols to ensure systems meet required specifications. Ensure all validation processes align with regulatory requirements and industry best practices, maintaining up-to-date software compliance. Assist in both internal and external audits, regulatory inspections, and assessments, ensuring systems meet all compliance and quality standards. Perform risk assessments to determine validation needs and ensure thorough coverage during validation activities. Participate in change control processes to ensure validated systems remain compliant following updates or changes. Work with IT, Development, and Regulatory teams to ensure project requirements are met and provide internal training on CSV and SDLC practices. Monitor the quality of the final product, ensure compliance, control code release mechanisms, and manage action items from exited employees. Review processes, suggest improvements, maintain project documentation, perform audits, and handle LMS and software support tasks efficiently.
