and audits, both internal and external Excellent communication and stakeholder engagement skills across cross-functional teams Familiarity with electronic quality systems (such as LIMS, TrackWise or Documentum) is advantageous Scientific or technical background preferred More ❯
CSC Regulatory Tracker, ArisGlobal Register, OpenText, SharePoint, Documentum, FirstDoc/FirstPoint, NextDocs, CARA, Salesforce, Workday, Oracle, SAP, Lorenz Docubridge, Extedo eCTD Manager, Master Control, Trackwise, other regulatory information management or submission publishing systems, etc. Consulting experience, working with a major system integrator or software vendor Regulatory Affairs, Regulatory Operations More ❯
CSC Regulatory Tracker, ArisGlobal Register, OpenText, SharePoint, Documentum, FirstDoc/FirstPoint, NextDocs, CARA, Salesforce, Workday, Oracle, SAP, Lorenz Docubridge, Extedo eCTD Manager, Master Control, Trackwise, other regulatory information management or submission publishing systems. Consulting experience, working with a major system integrator or software vendor. Regulatory Affairs, Regulatory Operations or More ❯
and closure of required documentation quality records e.g. DCFs, Tasks and CAPAs Creation and coordination of Change controls and completion of change assessments in Trackwise in conjunction with internal Lonza donors Maintenance of GMP document templates and document style and format standards Advise on document style and content, use More ❯
and closure of required documentation quality records e.g. DCFs, Tasks and CAPAs Creation and coordination of Change controls and completion of change assessments in Trackwise in conjunction with internal Lonza donors Maintenance of GMP document templates and document style and format standards Advise on document style and content, use More ❯
Control Laboratory and the Quality Systems operate in accordance with the requirements of the departmental Standard Operating Procedures. Role Responsibilities: Ensure EML's Electronic TrackWise Quality Management System (QMS) and Quality Control Laboratory systems and software used to support the manufacture, packaging, testing, storage and distribution of marketed drug … to the review and writing of any associated quality policies, systems and procedures as required. Support the maintenance and administration of EML's Electronic TrackWise Quality Management System (QMS) to maintain an effective QMS to meet EML's requirements. Support the effective management of the administration of QC laboratory More ❯
