Senior QA Engineer dedicated to manual testing for Pepperstone's fintech mobile trading application. Collaborating with Product and Tech teams for quality assurance and test planning in agile sprints.
About the role
- Verify and enhance quality systems in Global Pharmacovigilance at Chiesi, a biopharmaceutical company. Manage PV audits and contribute to global quality assurance initiatives.
Responsibilities
- To verify that the quality system implemented both at Global and Affiliate level is coherent and compliant with internal procedures and regulatory requirements.
- To ensure continuous improvement of the quality processes at Global and Affiliate level with regard to Pharmacovigilance.
- To manage PV Audits to Chiesi Pharmacovigilance System (PV System and PV process Audits to Global Pharmacovigilance and Affiliates, PV Audits to Business Partners, PV Qualification and Maintenance Audits to Service Providers, PV Audit to PASS), including the risk-based planning, the audit conduction and the monitoring of the CAPA implementation and effectiveness;
- To contribute to the development and execution of the global PV audit strategy (both long-term and annual planning)
- To cooperate in the selection and management of the PV QA Service Providers;
- To review the PV SOPs related to the PV System to ensure harmonization and compliance with current regulations and corporate requirements;
- To write SOPs/WIs related to the PV Audits activities;
- To cooperate in the planning and execution of PV Audit trainings to Global and Affiliates PV personnel;
- To cooperate in the maintenance and the quality review of the PSMF;
- To act as QA PV partner providing expert inputs in the projects/activities for Global Patient Safety and Chiesi affiliates personnel;
- To cooperate to manage quality metrics for PV Audits
- To engage with QPPV, senior QA/PV leaders, and cross‑functional stakeholders
Requirements
- At least 5+ years experience as Pharmacovigilance Auditor in Pharmaceutical Companies or as Pharmacovigilance Auditor Consultant involved in international projects.
- At least 5+ experience in Global PV System management and/or Quality Management System and compliance activities applicable to Pharmacovigilance system in pharmaceutical companies or in PV Service Providers.
- Scientific Master’s degree
- English fluent
- Knowledge of GVP Modules, ICH and ISO principles
- Knowledge of PV Quality Management Systems in Headquarters of international pharmaceutical companies
- Knowledge of pharmacovigilance processes of Global PV System
- Knowledge of auditing technique
- Knowledge of training technique
Benefits
- comprehensive healthcare programs
- work-life balance initiatives
- robust relocation support
- performance bonuses
- flexible working arrangements
- remote work options
- tax assistance services for foreign colleagues
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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