- Merck & Co. (Rahway, NJ)
- … Assurance community, provide for and lead Quality Assurance oversight for computer system validation matters within the Global Development Quality ... systems and data analysis packages.Endorse and build Quality Management System elements into the end-to-end...and Quality Manuals governing equipment qualification and computer system validation activities.Consult, assess… more
- AUROBINDO (Durham, NC)
- …improve compliance and throughputSupport deplloyment of the electronic laboratory notebook system through training, validation script review, and validation ... Pharma USA, Inc. is committed to delivering a broad portfolio of quality , affordable generic pharmaceuticals to pharmacists and patients. Aurobindo Pharma USA, Inc.… more
- Merck & Co. (Lower Gwynedd, PA)
- Job DescriptionJob Description Data Systems Senior Scientist (P3), Regulated Bioanalytics, Integrated Logistics & Sample Management (ILSM)-Description The PDMB ... Regulated Bioanalytics Department is seeking a Data Systems Senior Scientist to join our Integrated Logistics and Sample Management group. -This role will support… more
- Eisai, Inc (Nutley, NJ)
- …skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. Ability to ... including audit and inspection management and oversight of the Quality management system . This role is responsible...and for-cause audits Knowledge of data integrity controls and systems quality for clinical area Strong analytical… more
- BioAgilytix (Durham, NC)
- …That means hands-on work designing Azure Data Factory and API integrations, automating data- quality checks, and setting up clear governance so everyone knows who can ... keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data governance framework, with hands-on… more
- Insmed Incorporated (San Diego, CA)
- … System Design & Development:Lead the setup, development, and validation of EDC systems , including configuration settings, integration with ... be responsible for the development and implementation of EDC systems to support clinical trials, ensuring data quality...ICH-GCP) and company SOPsPerform user acceptance testing (UAT) and validation of EDC systems to ensure data… more
- Aequor (Davie, FL)
- …Ensure systems meet GxP, FDA, and ISO standards through robust Computer Systems Validation (CSV) and documentation practices. Cross-Functional ... lead and support cross-functional initiatives across IT, OT, and controls systems in a GMP-regulated pharmaceutical manufacturing environment. This role will drive… more
- Merck & Co. (North Wales, PA)
- …ensuring that project plans are executed efficiently with timely and high- quality deliverables.For assigned projects the position serves as the statistical ... Primary Activities: Effective analysis and report programming development and validation utilizing global and TA standards and following departmental standard… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …must have experience working within an aseptic manufacturing facility, preferably in training/ system applications, quality systems , or learning management ... training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation , Technical Support, Supply Chain) that supports daily clinical… more
- Merck & Co. (Lower Gwynedd, PA)
- …laboratory notebooks, and other scientific applications-Experience performing computer system validations-#ProjectAdvance#EligibleforERPCurrent Employees apply ... and enable late-stage clinical trials through the generation of timely, high- quality regulated bioanalytical data. -A combination of molecular (eg, PCR), serology… more
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