- Integra LifeSciences (Irvine, CA)
- …or more of the following areas of validation : * Equipment Qualification * Process Validation * Cleaning validation * Computer System Validation * ... each essential duty Satisfactorily: + Generation and execution of qualification/ validation protocols including the generation, routing and approval of summary… more
- Actalent (Santa Ana, CA)
- …assist in process development and troubleshooting. Responsibilities + Maintain the validation program for computer systems, facilities, equipment, and ... We are seeking a dedicated Quality Technician to maintain and enhance our validation and calibration programs within an aseptic filling facility. This role involves… more
- Cognizant (San Francisco, CA)
- …+ Understanding of Pharma value chain, Products/ Platforms used. + Knowledge of FDA regulations for Computer system validation , Medical Device regulations, ... GAMP 5 + Knowledge of Test Automation, Understanding of Gen AI will be a plus. + Experience and proven track record of dealing with IT, business, C level executives. + Well-rounded consultant with the ability to cross-sell, up-sell across all functional areas.… more
- VTI Life Sciences (San Diego, CA)
- …the biggest companies in the Life Sciences industry. We are looking for a Computer System Validation (CSV) Specialist to be responsible for ensuring that ... in compliance with industry standards, regulatory requirements (such as FDA 21 CFR Part 11 and 820, Data Integrity,...Validation . + Must have experience working in an FDA -regulated environment. + Experience with Automation Equipment such as… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …CGTO & SAP SD, MM & PP modules, regulatory compliance (such as GxP and FDA ), and life sciences Quality Management and Batch Release processes. As an SAP CGTO ... Sciences manufacturing operations, ensuring alignment with industry regulations such as GxP, FDA , and 21 CFR Part 11. Design scalable, efficient, and compliant… more
- Terumo Neuro (Aliso Viejo, CA)
- …quality assurance such as design control, risk analysis, design verification, design validation , process validation , test method validation , statistical ... + Work with R&D on design verification and design validation testing of new products. + Work with R&D...and data analysis. 3. Demonstrated command and knowledge of FDA and ISO medical device quality system requirements. 4.… more
- Abbott (Alameda, CA)
- …addressing moderate scope problems. + Participate in software development, verification, and validation under guidance. + Adhere to FDA -compliant Design Control ... **The Opportunity** The Embedded Software Engineer oversees the design, development, and validation of software for embedded systems, ensuring compliance with FDA… more
- Abbott (Sylmar, CA)
- …of FDA , GMP, IEEE 1012 and ISO 13485. Advanced computer skills, including tatistical/data analysis and report writing skills. Advanced Information Technology ... maintenance. + Documentation: Develop and maintain documentation in compliance with FDA , ISO, and other regulatory requirements. Apply sound, systematic problem… more
- Abbott (Sylmar, CA)
- …R&D in the completion of system/software requirements and other verification and validation processes related to embedded software products. + Participate in reviews ... provide useful feedback. + Create and execute or direct software validation protocols traceable to system/software requirements. Execute and support on-time… more
- Terumo Neuro (Aliso Viejo, CA)
- …accurate, high quality clinical data and adhering to Good Clinical Practices and FDA regulations. Job duties: + Develop and implement SOPs to ensure GCP/ICH ... as appropriate. + Assure regulatory compliance of vendors with company SOPs, FDA and ICH guidelines and other applicable regulations and guidelines. + Review… more