Quality Assurance Specialist IV (Compliance)
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| Job Type | Contractor |
| Location | Dublin |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | February 2023 |
| Advertiser | Ashling Guthrie |
| Telephone | 098-39159 |
| Job Ref | 2804 |
| Job Views | 288 |
- Description
- Team Horizon is seeking a Quality Assurance Specialist IV on an initial 12-month contract for our client, who are a leading biopharmaceutical company based in Dublin. Working within the Quality Compliance team, you will be responsible for providing 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.
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
What you will be doing:
Integrates knowledge and experience as skilled specialist with knowledge of corporate and industry standards with respect to area.
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
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.
Any other duties as assigned
What you need to apply:
8 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.
Bachelor’s degree (or equivalent) in a technical or life sciences discipline (ex. Chemistry, Biology, Biotechnology)
