| Resume alert | Resumes 61 - 70 of 743 |
Data Management Clinical
San Jose, CA
... Good understanding of International Conference of Harmonization/Good Clinical Practice (ICH GCP) Guideline and good understanding on FDA. Education: Rajiv Gandhi University of health sciences, India Doctor of Pharmacy – Pharm D Project- Clinical ... - 2023 Sep 27
... Good understanding of International Conference of Harmonization/Good Clinical Practice (ICH GCP) Guideline and good understanding on FDA. Education: Rajiv Gandhi University of health sciences, India Doctor of Pharmacy – Pharm D Project- Clinical ... - 2023 Sep 27
Senior Project Manager
Oakland, CA
... Core Competencies • Extensive Project Management experience in FDA-regulated industries • US FDA 21 CFR 820 (QSR/cGMP), EU IVDR/MDR, CMDR • ISO-3485, -10993, -14971, IEC60601 • Advanced Technical Writing • Proficient with MS Project, Smartsheet, MS ... - 2023 Sep 25
... Core Competencies • Extensive Project Management experience in FDA-regulated industries • US FDA 21 CFR 820 (QSR/cGMP), EU IVDR/MDR, CMDR • ISO-3485, -10993, -14971, IEC60601 • Advanced Technical Writing • Proficient with MS Project, Smartsheet, MS ... - 2023 Sep 25
Configuration Management Life Cycle
San Jose, CA
... Coordinating and scheduling software releases from internal engineering to production systems recording change execution to comply with SOX, FDA, CLIA (Clinical Laboratory Improvement Amendments) and other auditing requirements. Proposing and ... - 2023 Sep 10
... Coordinating and scheduling software releases from internal engineering to production systems recording change execution to comply with SOX, FDA, CLIA (Clinical Laboratory Improvement Amendments) and other auditing requirements. Proposing and ... - 2023 Sep 10
Document Control Quality Assurance
San Mateo, CA
... GMP, GCP, GMED and FDA experience. ●4+ years of training experience (training new hires) and building curriculums for each department. ●Built, implemented and validated Electronic Document Management Systems for 3 companies. ●20+ years as Subject ... - 2023 Sep 09
... GMP, GCP, GMED and FDA experience. ●4+ years of training experience (training new hires) and building curriculums for each department. ●Built, implemented and validated Electronic Document Management Systems for 3 companies. ●20+ years as Subject ... - 2023 Sep 09
Supply Chain Six Sigma
San Jose, CA
... Supported ISO 13485-2003, cGMP and QSR 21CFR820.50 and FDA audits ERP experience with Oracle and MS Dynamics Great Plains. Experience of start-up environment, low volume high mix as well as high volume production Deep understanding of manufacturing ... - 2023 Aug 20
... Supported ISO 13485-2003, cGMP and QSR 21CFR820.50 and FDA audits ERP experience with Oracle and MS Dynamics Great Plains. Experience of start-up environment, low volume high mix as well as high volume production Deep understanding of manufacturing ... - 2023 Aug 20
Data Entry Document Control
Santa Clara, CA
... Enforce - through functional groups - document control requirements in order for Ariosa to meet internal and external needs according to CLIA/CAP, NY, ISO 13485, IVDD, and FDA (QSR) regulatory standards including all applicable local, state, ... - 2023 Jun 20
... Enforce - through functional groups - document control requirements in order for Ariosa to meet internal and external needs according to CLIA/CAP, NY, ISO 13485, IVDD, and FDA (QSR) regulatory standards including all applicable local, state, ... - 2023 Jun 20
Mechanical Engineering Director
San Jose, CA
... Line Development Product Quality Improvement (QFD/RAM) Research & Development / IP / Patents Quality Standards & Compliance (ISO/FDA) Engineering Design&Product Development Verification / Validation / Risk analysis / DHF Cost Optimisation/ Product ... - 2023 Jun 14
... Line Development Product Quality Improvement (QFD/RAM) Research & Development / IP / Patents Quality Standards & Compliance (ISO/FDA) Engineering Design&Product Development Verification / Validation / Risk analysis / DHF Cost Optimisation/ Product ... - 2023 Jun 14
Sas Programmer Data Analyst
Fremont, CA
... Created Patient narratives and generated .XML outputs for FDA regulatory submissions. Worked closely with team Statistician and prepared Adhoc reports for analysis. Created edit check programs to find data discrepancies in raw datasets. Programed ... - 2023 May 25
... Created Patient narratives and generated .XML outputs for FDA regulatory submissions. Worked closely with team Statistician and prepared Adhoc reports for analysis. Created edit check programs to find data discrepancies in raw datasets. Programed ... - 2023 May 25
Member Team Financial Officer
Lafayette, CA
... Responsible for CIP validation system Responsible for statistical analysis of validation data with FDA officer Managed calibration systems for validation tests Education Master of Business Administration (MBA) Degree Finance University of San ... - 2023 May 10
... Responsible for CIP validation system Responsible for statistical analysis of validation data with FDA officer Managed calibration systems for validation tests Education Master of Business Administration (MBA) Degree Finance University of San ... - 2023 May 10
Medical Writer Technical
San Jose, CA
... • Have an insight on ICH, EMA and FDA guidelines. Participated in Hackathon event, where I gained exposure in Design thinking and prototype building. • - 2023 May 02
... • Have an insight on ICH, EMA and FDA guidelines. Participated in Hackathon event, where I gained exposure in Design thinking and prototype building. • - 2023 May 02