| Resume alert | Resumes 21 - 30 of 1002 |
Risk Management Data Architecture
North Bergen, NJ
... The entire software followed FDA regulations like PDMA and 21 CFR for sample validations rules. Environment: Oracle PL/SQL, C++, VB6, ASP, Sybase, HTML, JavaScript, XML, Perl Scripting, UNIX Shell Scripting. Sample Management as per CFR 21 Oct 1998 ... - Mar 31
... The entire software followed FDA regulations like PDMA and 21 CFR for sample validations rules. Environment: Oracle PL/SQL, C++, VB6, ASP, Sybase, HTML, JavaScript, XML, Perl Scripting, UNIX Shell Scripting. Sample Management as per CFR 21 Oct 1998 ... - Mar 31
Drug Safety Information Technology
Belle Mead, NJ
... • Expert knowledge of Global and FDA Regulations supporting the submission of Adverse Events for Post- marketing and Clinical Trials drugs. • Understanding of ICH guidelines on PV and application of guidelines detailed in FDA 21 CFR Part 11, ... - Mar 29
... • Expert knowledge of Global and FDA Regulations supporting the submission of Adverse Events for Post- marketing and Clinical Trials drugs. • Understanding of ICH guidelines on PV and application of guidelines detailed in FDA 21 CFR Part 11, ... - Mar 29
Business Analyst Change Management
Iselin, NJ, 07067
... Good Automated Manufacturing Practices (GAMP 5) risk-based approach Provided Validation services in achieving the 21 CFR PART 11 (Electronic Records & Signatures) compliance to assure successful data quality and data integrity to, and FDA challenge. ... - Mar 28
... Good Automated Manufacturing Practices (GAMP 5) risk-based approach Provided Validation services in achieving the 21 CFR PART 11 (Electronic Records & Signatures) compliance to assure successful data quality and data integrity to, and FDA challenge. ... - Mar 28
Data Entry Warehouse Associate
Newark, NJ
... Lupin Pharmaceuticals Somerset, NJ 01/2022 - 11/2022 Warehouse associate/Material Handler Current good manufacturing Practice regulation enforced by the FDA. Performed cycle counts and inventory control to accurately track product levels. Fastened ... - Mar 28
... Lupin Pharmaceuticals Somerset, NJ 01/2022 - 11/2022 Warehouse associate/Material Handler Current good manufacturing Practice regulation enforced by the FDA. Performed cycle counts and inventory control to accurately track product levels. Fastened ... - Mar 28
Project Manager Change Management
Bridgewater, NJ
... Developed online Learning Management System (LMS) for certification process training and to meet FDA / compliance requirements. Provided guidance on change management methodology and related communications for stakeholder and user clarity. Ricoh ... - Mar 26
... Developed online Learning Management System (LMS) for certification process training and to meet FDA / compliance requirements. Provided guidance on change management methodology and related communications for stakeholder and user clarity. Ricoh ... - Mar 26
Forklift Operator Inventory Control
Newark, NJ
... • Knowledge of cGMP/FDA regulated industry Education High school diploma Piscataway High School - Piscataway, NJ Baskerville Institute Skills • Forklift • Ups/fedex • Operator certification • Time Management • Manufacturing • Warehouse management ... - Mar 26
... • Knowledge of cGMP/FDA regulated industry Education High school diploma Piscataway High School - Piscataway, NJ Baskerville Institute Skills • Forklift • Ups/fedex • Operator certification • Time Management • Manufacturing • Warehouse management ... - Mar 26
Quality Assurance Project Management
North Brunswick, NJ
... Document Management System), SAP(System Applications products in Data Processing) - Provide all necessary documents to FDA, visitors and auditors by putting uncontrolled copies stamp - To maintain all inventories required for documentation. ... - Mar 17
... Document Management System), SAP(System Applications products in Data Processing) - Provide all necessary documents to FDA, visitors and auditors by putting uncontrolled copies stamp - To maintain all inventories required for documentation. ... - Mar 17
16+ years in Pharmacovigilance. Phase I clinical drug trials as a RN
Edison, NJ, 08817
... Decreased possible late cases through root cause analysis of non-compliant single case reports, circumventing FDA audits and fines, resulting in significant overall savings. Drug Safety Associate Consultant Experience: G & W Laboratories, Inc., ... - Mar 15
... Decreased possible late cases through root cause analysis of non-compliant single case reports, circumventing FDA audits and fines, resulting in significant overall savings. Drug Safety Associate Consultant Experience: G & W Laboratories, Inc., ... - Mar 15
Senior Technical Writer
Morris Plains, NJ
... and foreign RRD regulatory to ensure compliance with FDA, INVIMA, and ANVISA submissions. ·Supported activities to maintain RRD product marketability in U.S. and foreign markets upon CMO change. ·Developed and fostered existing relationships with ... - Mar 15
... and foreign RRD regulatory to ensure compliance with FDA, INVIMA, and ANVISA submissions. ·Supported activities to maintain RRD product marketability in U.S. and foreign markets upon CMO change. ·Developed and fostered existing relationships with ... - Mar 15
Program Management Gene Therapy
Wood Ridge, NJ
... company from Discovery through multiple IND approvals, IPO and M&A • Experience with implementing CMC strategies based on FDA/EMA guidance in Neurodegenerative and Pain diseases • Leader for technical teams in various departments including CMC, ... - Mar 11
... company from Discovery through multiple IND approvals, IPO and M&A • Experience with implementing CMC strategies based on FDA/EMA guidance in Neurodegenerative and Pain diseases • Leader for technical teams in various departments including CMC, ... - Mar 11