AZNJP00028350-Specialist Quality Systems-Dublin/Athlone Contractor

This is an 8-month contractor position. Hybrid position – 3 days onsite, 2 days remote.

Purpose

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 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.

Requirements

• Bachelor’s degree (or equivalent) in a technical or life sciences discipline (ex. Chemistry, Biology, Biotechnology)
• 6 years’ + experience in Pharmaceutical, Device or Commercial Quality Assurance within the biopharmaceutical or pharmaceutical industry.
• Prior experience creating and delivering training required.
• Direct experience with development and approval of deviations, CAPAs, Change Controls and laboratory investigations.
• Prior experience in a Global QA role 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 required.
• Experience using Veeva Vault eQMS desired.