Quality Assurance Team Lead
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| Job Type | Permanent |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #1002001 |
| Job Views | 303 |
- Description
- We are seeking applications for our client, who are a leading biopharmaceutical company based in Dublin. The successful candidate will interface globally with users across Global Operations, Commercial, Research & Development, IT and Quality to support execution and monitoring of the global Quality Management System (QMS) governing Deviation, CAPA and Change Control.
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.
Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
What you will be doing:
Collaborate with global stakeholders to identify, plan and lead implementation of value-added improvements to the QMS
Assist global business partners with the creation, review, approval, closure and monitoring of deviations, investigations, CAPAs, change controls.
Liaise with global stakeholders to identify, plan and lead implementation of value-added improvements to the QMS.
Proactively identify and communicate risks, issues, and best practices within the QMS.
Set up new and improve existing forums for performance monitoring and end user support.
Create and update QMS procedural documentations and work instructions with accuracy and clarity.
Create and deliver QMS training (process and technical).
Participate in inspection readiness activities, self-inspections of the QMS and external audits.
Other duties as required to support the growing quality organization.
What you need to apply:
Bachelor’s degree in a technical or life sciences discipline (ex. Chemistry, Biology, Biotechnology).
12 years’ + experience in quality systems within the pharmaceutical industry.
Prior managerial experience in a global QA role
Proven critical thinking and problem-solving skills.
Knowledge of global GCP, GLP, GVP, GMP and GDP requirements for quality systems, medical devices and combination products.
Direct experience with development and approval of deviations, CAPAs and Change Controls.
Experience in project planning and leadership within a matrix environment.
Experience training and coaching for skill development.
Brilliant written and verbal communication skills.
Able to plan, prioritize and manage workload and manage shifting priorities to ensure commitments are met.
Direct experience with TrackWise desired.
English language fluency
