QA Compliance Specialist
Hours: 40 hours per week, 8 hours per day
Initially remote role due to Covid restrictions, but long-term plan is to be back onsite/ remote mixed. Therefore we are looking for Irish Locals for this position.
About the role:
Sr. Specialist, Quality Systems, required to join the Central Quality Systems and Compliance team. This role will interface globally with users across Global Operations, Country Operations, Research & Development, IT and Quality Operations to support execution and monitoring of the enterprise Quality Management System (QMS) governing Deviation, CAPA and Change Control.
The ideal candidate will have the following experience:
- Strong experience in Quality within the pharmaceutical industry
- Prior experience in a Global QA role strongly preferred.
- Direct experience with development and approval of deviations, CAPAs and Change Controls.
- Knowledge of global GCP, GLP, GVP, GMP and GDP requirements for quality systems, medical devices and combination products.
- Direct experience with TrackWise desired
- Assist global GxP business partners with the creation, review, approval and closure of deviations, investigations, CAPAs, change controls and associated quality risk assessments in compliance with internal and external requirements.
- Create and deliver QMS training (process and technical).
- Create and update of QMS procedural documentation and work instructions.
- Extract and compile QMS data into reports for metrics and analysis.
- Completion of assigned projects and participation on global and local project teams, supporting delivery on time and in full.
- Participate in inspection readiness activities and internal/external audits and inspections.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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