Senior Specialist QA Scientific

at  Team Horizon

Team Horizon is seeking a Senior Specialist QA Scientific for our client based in Dublin. The Senior Specialist, Quality Systems, to join the Central Quality Systems and Compliance team.
This role serves as a pharmaceutical quality subject matter expert and supports global colleagues across Operations, Commercial, Device, IT and Quality partners. The successful candidate for this role must be able to work onsite in line with company requirements.

• Provides guidance to global GMP/GDP business partners to support compliant and timely execution of quality management systems (QMS) records such as deviations, investigations, CAPAs, change controls and laboratory investigations.
• Integrates knowledge and experience as skilled specialist with knowledge of corporate and industry standards with respect to area.
• Creates and delivers QMS training and coaching (process and technical).
• Creates, owns, and manages deviations, change controls, and CAPA in TrackWise.
• Creates, updates, reviews, approves and implements QMS procedural documentation and work instructions with accuracy and clarity.
• Completes assigned projects, supporting delivery on time and in full. Provides regular updates on progress.
• Leads and participates in internal forums, for example Change Control Review Board, CAPA Review Board and Communities of Practice.
• Compiles and analyses QMS data to assess compliance, identify trends and generate new insights. Provides recommendations for continuous improvement supported by data and analysis.
• Participates in inspection readiness activities and internal/external audits and inspections.