JobMesh

Quality Assurance Consultant (QA with PV Support)

TFS HealthScience · SE

TFS HealthScience is a leading global mid size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout...

Job description

About this role TFS HealthScience is a leading global mid size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourcing, and Functional Service (FSP) solutions. The Quality Assurance Consultant QA with PV support is responsible for providing hands on operational QA support and selected Pharmacovigilance administrative activities to ensure ongoing compliance with applicable regulations and internal quality systems. The role supports business continuity during periods of high workload and planned absence. As part of our SRS FSP team, you will be dedicated to one sponsor, a global pharmaceutical or biotechnology company that is an industry leader within its therapeutic area. This is a part‑time consultancy assignment corresponding to approximately 0.4 FTE per month. Key Responsibilities: - Operational handling of quality deviations, incidents and complaints, including root cause analysis and CAPA activities, and support in change control when required - Update, maintenance and lifecycle management of SOPs and support in KPI follow...