Quality Assurance Manager
Date Posted23 Apr 2020
This vacancy has now expired
Quality Assurance Manager, Global Biotech Company, DublinAn exciting new opportunity for a Quality Systems Manager to join a world Leading bio tech organisation who are at a peak phase in establishing an innovative and industry leading manufacturing facility in Dublin Ireland.
Working in a state of the art Biotechnology facility, we are looking for a Quality Systems Manager, to join the Quality Scaled and Digital Services team.
This role will interface globally with users across Global Operations, Commercial, Research & Development, IT and Quality to support execution and monitoring of the enterprise Quality Management System (QMS).
The standard hours for this role are 7:00AM – 3:30PM Monday-Friday; support outside of standard hours may be required on occasion.
For this role, we are looking for Senior Level candidates with strong and recent experience in the Pharmaceutical / Biotechnology Industry.
DUE TO TRAVEL RESTRICTIONS CAUSED BY THE CORONAVIRUS WE CAN ONLY ACCEPT APPLICATIONS FROM THOSE RESIDING IN IRELAND AT THIS TIME
Key Duties in the QA QMS role are as follows:
- Use deep process knowledge and experience to assist business partners with the creation, review, approval, closure and monitoring of deviations, investigations, CAPAs, change controls and associated quality risk assessments in compliance with internal and external requirements
- Collaborate with stakeholders to identify and implement value-added improvements to the QMS.
- Establish new and improve existing forums for performance monitoring and end user support.
- Proactively identify risks, issues and best practices within the QMS on an ongoing basis (audits, visual management systems, dashboards, status reports etc.).
- On-time completion of assigned projects.
- Author, review and approve QMS procedural documentation and working practice documents.
- Create and deliver Quality Systems training (process and technical).
- Compile, analyse and present QMS monthly and quarterly metrics at Quality Management Review.
- Participate in inspection readiness activities and internal/external audits and inspections.
- Other duties as required to support the growing Quality organisation.
A successful applicant for the position of QMS Manger will have:
- In-depth knowledge of global GCP, GLP, GVP, GMP and GDP requirements for quality systems.
- Demonstrated critical thinking and problem-solving skills.
- Direct experience with development and approval of deviations, CAPAs and Change Controls.
- Prior experience in project leadership within a matrix environment.
- Prior experience training and coaching for skill development.
- Excellent communication skills with all levels of the organization and Health Authority representatives.
- Able to prioritize and manage workload and manage shifting priorities based on criticality to ensure commitments are met.
- Direct experience with TrackWise desired.
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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