18169876-Senior QA Specialist-Dublin Contractor

This is a 12-month initial contract with a strong view to extension.

Purpose:

We are seeking a Full Time Contract Sr. 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.

Responsibilities:

• 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 a skilled specialist with knowledge of corporate and industry standards with respect to the area.
• Create and deliver QMS training and coaching (process and technical).
• Creates owns, and manages deviations, change controls, and CAPA in TrackWise.
• Create, update, review, approve and implement QMS procedural documentation and work instructions with accuracy and clarity.
• Completion of assigned projects, supporting delivery on time and in full. Provides regular updates on progress.
• Lead and participate in internal forums, for example, the Change Control Review Board, CAPA Review Board, and Communities of Practice.
• Compile and analyze QMS data to assess compliance, identify trends and generate new insights. Provide recommendations for continuous improvement supported by data and analysis.
• Participate in inspection readiness activities and internal/external audits and inspections.

Requirements:

• Bachelor’s degree (or equivalent) in a technical or life sciences discipline (ex. Chemistry, Biology, Biotechnology)
• 6 years + of experience in Pharmaceutical, Device, or Commercial Quality Assurance within the biopharmaceutical or pharmaceutical industry.
• Prior experience creating and delivering training is required.
• Direct experience with the development and approval of deviations, CAPAs, Change Controls, and laboratory investigations.
• Prior experience in a Global QA role is preferred.
• Able to plan, prioritize and manage workload and manage shifting priorities to ensure commitments are met.
• Demonstrated critical thinking and problem-solving skills.
• Knowledge of global GMP and GDP requirements for quality systems, medical devices, and combination products.
• Excellent written and verbal communication skills.
• Experience using TrackWise is required.
• Experience using Veeva Vault eQMS desired.