Quality Systems Manager

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A Global Leader in Biopharmaceutical industry are seeking a Quality Systems Manager to join their Quality operations team based in Co.Dublin.

This is an exciting opportunity to work as part of an agile and patient centric company who strive to improve lives through science and compassion.Your New Role

As a Quality Systems Manager you will be responsible for managing quality systems in compliance with all regulatory requirements.

Alongside applying quality assurance principles to the design, validation, implementation and management of the systems.

Your Duties and Responsibilities as Quality Systems Manager

- Responsible for managing corporate QMS as a System Administrator.

- 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.

- Supports the expansion of and manages the quality management systems (Change Control, Deviation, CAPA), including managing the review of these systems and reporting appropriate metrics.

- 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.

- Accountability for understanding and applying quality system standards.

- Coordinating annual self-inspection program for the Dublin site, in discussion and alignment with Corporate Quality global self-inspection schedule.

- Communication with Regulatory Authorities concerning licenses and inspections.Your Education & Experience

- Possess knowledge and experience in a GxPs regulated industry in multiple geographies.

- 4-6 years of experience in pharmaceutical Quality, preferably Quality Systems.

- Bachelor of Science or relevant field of study.Your Skills & Competencies

- Thorough understanding and background in Quality Management System Management.

- Previous experience creating and presenting metrics on QMS.

- Auditing experience (internal or external) would be an advantage.

- Strong computer skills (e.g. Microsoft applications such as Word, Excel, PowerPoint, etc.) with proven skills for generating reports, presentations and statistics.

- Experience with Compliance Wire LMS preferable but not essential.What's in it for you?

You will receive a competitive salary and attractive benefits package.

And further to this the opportunity to join an award winning Biopharmaceutical Company that has been recognised for it's outstanding company culture and workplace best practices.

Your Next Step

If this sounds like the right role for you, please reply with an updated CV for immediate consideration.

Or if you would like to hear more please feel free to contact Ciara McGrath on 01 8883477 or by email. To find out more about Real please visit www.realstaffing.comReal 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