Lisbon, Lisbon, Portugal
• Work with internal teams to progress quality issues in Quality Management System (QMS) • Tracks timeliness of quality issues in QMS • Support internal teams in creation of quality issues CAPA plans (including investigation, root cause analysis, CAPA actions and effectiveness checks) • Maintain strong working knowledge of QMS and applicable regulations • Interact with applicable internal team members for quality issues progression and client notifications • Pull metrics data, trending and tracking of quality issues • Interact with client QA counterparts to review QA-related topics (including status of quality issues and audit findings) on a frequent basis • Interact with client QA counterpart and client senior management during governance meetings, discussing QA topics that require escalation and presenting QA metrics review, as applicable • Support the creation/review of Quality Agreements as required • Support audit team during client audits or regulatory inspections as needed • Support the internal teams in GxP related questions as needed
- Ensure that the quality system always complies with the applicable requirements (namely ISO 9001 and ICH-GCP) - Support in the definition of KPIs of Eurotrials Units, as well as suggesting additional KPIs for QA Unit - Responsible for revising Eurotrials Documents (namely SOPs) in order to ensure adequacy of all Units’ SOPs with Eurotrials Quality Management System - Support the elaboration and update of the Internal Quality Audit Planning - Perform oversight of Eurotrials staff’ training compliance in liaison with Human Resources Unit - Ensure the escalation of problems/ difficulties and supporting in the definition of potential solutions - Coaching and oversight of activities conducted by QA junior staff
- Performance of projects, processes and vendors audits as per the Annual Internal Quality Audit Plan - Performing the oversight and follow-up open/pending CAPAs
- Support the accomplishment of regular reviews of the suitability and effectiveness of the Quality Management System as well as in the definition of Key Performance Indicators - Control and management of Quality System Documentation, as well as prepare and review SOPs - Support the preparation of Audits and Inspections as well as follow-up actions and CAPA oversight - Assessment of vendors - Receive, analyse and ensure proper compilation of client satisfaction and complaints - Support the control and continuous improvement of training process