A biopharmaceutical company in Dublin focused on improving patient's lives by identifying, developing, acquiring and commercialising differentiated and accessible medicines that address unmet medical needs. Core values include Growth, Accountability, and Transparency.
I am currently working in close partnership with the company in Dublin in search of a Quality Systems Manager.This is a hands-on position, applying quality assurance principles to the design, validation, implementation and management of systems including but not limited to quality related records and training. This is a great opportunity to join a growing organisation and develop your skills.
What you will be doing:
You will be responsible for managing the company's quality systems in compliance with all regulatory requirements. We are seeking a Quality System Manager with a background heavily system focused to:
- Responsible for managing corporate Quality Management Systems as a System Administrator (e.g. Veeva Quality Vault).
- In collaboration with IT, and functional leads, supports document management process design and execution. Supports the expansion of and manages the document management systems for GxP documents
- Assist in annual Quality Management Review activities
- Coordinating annual self-inspection program for the Dublin site, in discussion and alignment with Corporate Quality global self-inspection schedule.
- Assist in preparations for internal/third-party/regulatory inspections, including assisting in preparing audit reports and responses to observations, providing recommended conclusions and actions with implementation
This role requires good judgement and strong initiative. You need to have the ability to effectively prioritise and manage a diversified workload, often to strict deadlines. You should have strong interpersonal skills, a professional approach with excellent written and verbal communication skills.
4+ years of experience in pharmaceutical Quality, preferably Quality Systems
Strong understanding and background in Quality Management System Management.
Auditing experience (internal or external) would be an advantage
Ability to travel approximately 5% on average, including trips abroad
For immediate consideration apply with an up to date CV.
No CV ready? Not sure yet? Please get in touch for more info.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales