Quality , Science, Pharmaceutical & Food
Senior Quality Systems Specialist
- Contract
- North Dublin, County Dublin, Ireland
- 42013493
PE Global are currently recruiting for a Senior Quality Systems Specialist for a client site in Dublin.
Initially 8 Month Contract – Hybrid
Key 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.
Qualifications & Experience:
- 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.
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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