Located 15 minutes from Dublin Airport and just a short distance from the lively, vibrant, and cultural Irish capital, this leading biopharmaceutical organisation leads the way with state of the art technology on their one of a kind manufacturing facility.
Essential Duties and Responsibilities for this role include, but are not limited to, the following:
- Use deep process knowledge and experience to assist 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
- Proactively identify opportunities and support continuous improvement of enterprise QMS processes and associated systems
- On-time completion of assigned project
- Monitor QMS process performance to identify trends and best practices on an ongoing basis (audits, visual management systems, dashboards, status reports etc.
- Author, review and approve of QMS procedural documentation and work instruction
- Create and deliver Quality Systems training (process and technical)
- Compile, analyse and present QMS monthly and quarterly metrics at Quality Management Review
- System user access management
- Participate in inspection readiness activities and internal/external audits and inspections.
- Other duties required to support the growing Quality organization as assigned.
- QA experience within the pharmaceutical/ biopharmaceutical industry.
- Significant, direct experience with development and approval of a minimum of two of the following: Deviations, CAPAs, Change Controls and quality risk assessments
- In-depth knowledge of global cGxP requirements for quality systems.
- Experience working with stakeholders in pre-commercial, manufacturing, laboratory and distribution functions.
- Excellent communication skills with all levels of the organization and Health Authority representative.
- Direct experience with TrackWise desired.
- Project Management and Lean Six Sigma certifications a plus.
If this role is of interest, please apply now.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
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