Quality Assurance Specialist - Veeva Systems

• 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.

• 6 years' + experience in Pharmaceutical, Device or Commercial Quality Assurance within the biopharmaceutical or pharmaceutical industry.
• Prior experience creating and delivering training advantageous.
• 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 or Veeva required.
• Experience using Veeva Vault eQMS desired.

• Bachelor's degree (or equivalent) in a technical or life sciences discipline (ex. Chemistry, Biology, Biotechnology)

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