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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.
