Quality Assurance Specialist – Veeva Systems

Barden are delighted to be supporting our Global client based in Dublin in their search for a Senior Quality Systems Specialist. 

ABOUT THE ROLE:

This role serves as a pharmaceutical quality subject matter expert and supports global colleagues across Operations, Commercial, Device, IT and Quality partners.

Principal 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.

ABOUT THE PERSON:  

Qualifications

• 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.

Education

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

Hi, we’re Barden.  We’re the Partner Led Talent Advisory & Recruitment Firm that puts Talent first. With practices across Accounting & Tax, Business Support, Financial Services, Life Sciences, Legal, Supply Chain, and Technology, we help build world-class teams for Ireland’s top companies and we help top Talent achieve their ambitions.Simple.