As a Quality Assurance Specialist you participate in projects related to audit and inspection management, process improvement, controlled document management and compliance management, representing QMS and taking ownership for specific tasks and deliverables. This to ensure oversight over applicable pharmacovigilance regulations.
In this role you are reporting to a QMS or Process Improvement team lead. As a member of a QMS team you contribute to the development, implementation and successful execution of strategic plans.
- Implementing and maintaining pharmacovigilance tools and processes;
- Ensuring continuous monitoring on compliance, timeliness and quality metrics;
- Reporting on metrics of pharmacovigilance processes;
- Providing feedback on performance to functional groups;
- Supporting audits;
- Acting as a member of an inspection operational team;
- Coordinating the preparation of audit/inspection responses;
- Monitoring compliance with timelines for inspection/audit responses, internal commitments and effectiveness