Maintains all aspects of the controlled document and internal employee training programs in accordance with GxP (specifically GCP and GMP) and relevant local and international standards.
January 30, 2020
Provide QA Validation support for GxP systems to ensure the maintenance of compliance with the applicable validation programs for the qualification/validation of utilities, facilities, equipment, and processes.
March 15, 2020
Supports the annual roll-out of the Adverse Event Reporting Policy Training assigned to all company staff globally, which includes project management, facilitation of updates to the training content, evaluation of training adequacy, and appropriate distribution of training (with technical support from the LMS Administrator for LMS assignments).
May 11, 2020
Manages activities related to quality and compliance including but not limited to monitoring and trending of key performance indicators (KPIs) and compliance metrics reports relative to the safety reporting and regulatory submission of individual case safety reports (ICSRs) and aggregate periodic safety reports.
June 03, 2020
Develop and maintain a complete Corporate Global Trade training program including the review and valuation of trade professional and company awareness training determine appropriate training content, objectives and design.
June 08, 2020
Takes a lead role in the design and development of a procedural and standards program for CSPV based on corporate, organizational and individual needs working closely with CSPV management and other functions as applicable.
June 29, 2020
Lead the continuing effort to enhance divisional workforce management practices through process simplification, value-added tools, and timely metric reporting that the field can take action on or drive changes in behavior.
June 30, 2020