19 oct
|
ThermoFisher Scientific
|
Región de Murcia
19 oct
ThermoFisher Scientific
Región de Murcia
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description 1PURPOSE OF THE FUNCTION * The Global Patient Safety (GPS) Quality Management Manager is responsible for the operational execution of the Pharmacovigilance (PV) Quality Management System (QMS) in a consistent, effective and efficient way within the Integral Patient Safety functional area. * This position will also: * Contribute to driving the growth of the GPS Quality Management function. * Maintain & execute the Comprehensive Training Program. * Manage GPS Procedural Document activities * Participate in GPS Audit & Inspection Readiness, Support & Management. * Contribute to GPS Continuous Improvement (Issue Management, Process improvement, KPI development). 2REPORTING LINE * Associate Director, GPS Quality Management or above 3ROLES AND RESPONSIBILITIES GPV internal Audit program and Inspection activities: * Support, and/or manage GVP Audit & Inspection activities * Support internal global GVP audit program and inspection readiness activities in collaboration with the client Quality functional area.
* Prepare GPS team members on inspection readiness activities. * Ensure appropriate documents are readily retrievable to use during an Inspection (GPS inspection slides, CVs, JDs, PVAs are contact information is updated and readily available). * Support the coordination and preparation of GPS responses to audit &inspection; findings. Deviation & Corrective and Preventive Action (CAPA) activities: * Assess GPS issue management trends and implement actions plans to mitigate systemic causes. * Identify internal deviations and support / advise GPS team in determining corrective and preventive actions. * Support/guide the GPS team to determine root cause of issue to avoid recurrence. * In collaboration with the client Quality functional area, lead the implementation of corrective or preventive actions. Training, Procedural Document, & Record Management activities: * Contribute to the development of
📌 FSP Quality Manager (Región de Murcia)
🏢 ThermoFisher Scientific
📍 Región de Murcia