- KPMG (Houston, TX)
- **Business Title:** Manager, Trackwise Digital Architect - QMS **Requisition Number:** 113224 - 90 **Function:** Advisory **Area of Interest:** **State:** TX ... from an accredited college/university preferred + Experience configuring and implementing TrackWise Digital - Quality Management System for the Life Sciences… more
- Amicus Therapeutics (NJ)
- …enhancements and /or new releases of currently used electronic QMS systems ( Trackwise ), conduct training, update relevant procedures, and report metrics for QE ... Support and track enhancements or new releases of electronic QMS systems ( Trackwise ) or implementation of new electronic QMS systems. This includes system… more
- CGI Technologies and Solutions, Inc. (Cambridge, MA)
- …The ideal candidate will possess in-depth knowledge of both Veeva QMS and Trackwise platforms and have a strong background in using Jira and Agile methodologies. ... and processes to integrate and optimize Veeva QMS and Trackwise systems within our operations. * Lead the requirement...data integrity and system efficiency between Veeva QMS and Trackwise . * Develop and maintain inbound and outbound interfaces… more
- Kelly Services (Deerfield, IL)
- …aid them in user testing acceptance 3. Knowledge and/or Experience with Trackwise or other Quality Management Systems 4. Must be professional, assertive, articulate ... job in one to four sentences. Identify, evaluate, develop and/or update TrackWise QMS related validation package documentation to support project needs. Provide… more
- Boehringer Ingelheim (Gainesville, GA)
- …different areas. Record and maintain change controls and all documentation in the TrackWise system. Following up on overdue and those Change Controls that are coming ... & Responsibilities** + Track and Maintain Change Controls in TrackWise system. Follow up on outstanding change controls that...+ Responsible to learn other systems to include deviation/CAPA, Trackwise and IDEA for CON and be a back… more
- CBRE (Durham, NC)
- …scheduled outages with Manufacturing and Site Leadership, request outages when needed ** Trackwise / Compliance** + Lead adherence to client's SOP's and engineering ... requirements + Support change management activities via Trackwise + Review/approve Trackwise submissions + Partner with CBRE Quality to lead or support… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- …of commitments thereof Ensure effective communication and dissemination of commitments via TrackWise and other means. + Track, trend, report, and provide follow-up, ... audit/inspection commitments. + Facilitate approval of audit/inspection commitments via TrackWise and other means. + Author/compile on-demand, monthly, quarterly and… more
- CGI Technologies and Solutions, Inc. (Cambridge, MA)
- …in Quality Management Systems (QMS), using tools such as Veeva or Trackwise , and expertise with HP ALM for validation activities. The successful candidate ... the implementation and validation of systems using Veeva or Trackwise for QMS processes. * Ensure compliance with GxP...Management Systems (QMS) and tools such as Veeva or Trackwise . * Strong experience with validation processes and documentation,… more
- CGI Technologies and Solutions, Inc. (Cambridge, MA)
- …and IT aspects of Quality Management Systems (QMS), particularly in migrating data from TrackWise to Veeva QMS. The SME will play a critical role in responding to ... Plan and oversee the migration of QMS data from TrackWise to Veeva QMS. Ensure data integrity, accuracy, and...Administration, or related field. * Certification in Veeva and Trackwise would be preferable CGI is required by law… more
- Lilly (Durham, NC)
- …serves as a power user and data steward for the Complaint Management TrackWise / Veeva system and performs complaint investigations for RTP manufacturing, assembly, ... drug/device combination products and parenteral products. + Support and initiate TrackWise / Veeva Trend, RCI's, Tasks or other technical investigations, as… more
- Boehringer Ingelheim (St. Joseph, MO)
- …Assessment. + Performs operations related investigational activities as assigned in TrackWise child Investigation records in support of High-risk deviations / ... programs such as Microsoft suite, SAP, IDEA for CON, Learning One Source, TrackWise and other relevant electronic applications. + NOTE: Relevant BIAH experience may… more
- Randstad US (Lexington, MA)
- …job details job summary: Recommended Experience: + Service now, Veeva, Trackwise , Active Directory, firewall rules, My Access, + NTFS permissions. Excellent ... and Configuration Management (CMDB) Familiarity with following tools and processes - + TrackWise - CAPA, Deviation, Change Control + Veeva - Document Workflows +… more
- Catalent Pharma Solutions (Winchester, KY)
- …also provide validation support for change control to validated systems using TrackWise , and validation support during customer and agency audits / interaction with ... Proficiency in Microsoft Word, PowerPoint and Excel + Working knowledge of TrackWise software + Knowledge of SOPs pertaining to Catalent Pharma Solutions validation… more
- ThermoFisher Scientific (Bridgewater, NJ)
- …with laboratory SOPs and test methods. Use quality systems such as LIMS, TrackWise , and Oracle for routine daily work. Investigate the non-conformance of samples and ... submit reports in TrackWise for traceability. Support quality assurance investigations of product complaints with technical knowledge of the products and analytical… more
- Catalent Pharma Solutions (Madison, WI)
- …or laboratory reports + Initiate and lead investigations or deviations in TrackWise + Participate in team meetings and/or training sessions **EDUCATION AND** ... in specific analytical techniques. + Initiating and assisting with records in TrackWise . + Maintaining batch records and/or laboratory notebook and completing all… more
- ThermoFisher Scientific (St. Louis, MO)
- …do?** + Conduct RAPID meetings with QA and QC staff + Use TrackWise software to author investigations + Be responsible for compliance-related deliverables including: ... more years as an investigation writer, CAPA developer, or auditor. + TrackWise and TapRooT experience is preferred. **Knowledge, Skills, Abilities** + Knowledge of… more
- Fujifilm (Holly Springs, NC)
- …and reviewing SOPs, protocols, reports, change management reports, CAPAs and Trackwise deviations related to Sample Management and Stability Studies * Creates ... department or in an FDA regulated industry (drugs/biologics) * Experience using Trackwise system * Experience working in a laboratory environment is desired *… more
- Honeywell (Hamilton, NJ)
- …and efficacy and is built for productivity, sustainability, and transformation. The TrackWise digital quality management system is built to empower quality teams, ... and efficacy and is built for productivity, sustainability, and transformation. The TrackWise digital quality management system is built to empower quality teams,… more
- ManpowerGroup (Rocklin, CA)
- …device), validation and data control/integrity experience, as well as SAP and Trackwise knowledge, which will align successfully in the organization. **Job Title: ... in risk management/assessment (medical device), validation and data control/integrity + SAP and Trackwise knowledge is a plus **What's in it for me?** + Gain… more
- Honeywell (Hamilton, NJ)
- …and efficacy and is built for productivity, sustainability, and transformation. The TrackWise digital quality management system is built to empower quality teams, ... and efficacy and is built for productivity, sustainability, and transformation. The TrackWise digital quality management system is built to empower quality teams,… more