Responsibilities: Travel - Up to 90% field-based, including travel to Riverdale, CA and Irvine, CA. Serve as the primary liaison with UC ANR South Coast Farm to coordinate all StarFire GNSS test activities. Collaborate with engineering ...
Summary : The CSV Specialist will plan, execute, and document validation activities for GxP-regulated computerized systems. This role supports system lifecycle activities, audits, and compliance initiatives while ensuring adherence to FDA...
Responsibilities: Maintain and update EDC user access across multiple clinical studies Track and manage user access requests in coordination with CRAs and EDC vendors Curate and maintain standardized tracking spreadsheets for both...
Summary: Writing and execution of validation protocols and reports (i.e. IQ, OQ, PQ, etc.) Developing and implementing manufacturing processes, preparation of specifications and operator instructions, process studies, production readiness...
Job description: Our client is seeking an experienced Regulatory Operations Consultant to support Veeva Vault RIM, with a primary focus on archiving legacy regulatory content and mitigating documentation into Veeva Vault. This role will p...
Roles & Responsibilities: Leading supplier qualification activities for new components and processes. Planning, executing, and documenting IQ/OQ/PQ and component/process qualifications. Reviewing supplier documentation such as FAIs, pFM...
Job Summary: Must have at least 10 years of experience Must be bilingual (English/Spanish) Someone that can generate VMP, develop systems lists, provide all necessary plans for front end CQV planning documents along with scheduling. The...
Responsibilities: Provide leadership, strategic planning, direction and implementation of clinical systems for data collection which may include vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelin...
Roles & Responsibilities: Writing and execution of validation protocols and reports (ie. IQ, OQ, PQ, etc.) Developing and implementing manufacturing processes, preparation of specifications and operator instructions, process studies, pro...
Roles& Responsibilities: Lead the development, execution, and approval of validation master plans, validation plans, IQ/OQ/PQ protocols, and final reports, with emphasis on sterilization, endotoxin control, and microbiology-related proces...