Job Description
An amazing opportunity has arisen for a Quality & Data Integrity Risk Management Specialist. This role will be responsible for supporting the Quality & Data Integrity Risk Management Program for areas within the remit of Our Company’s Manufacturing Division Quality organization at Dunboyne Biologics.
What you will do:
* Support integration of a harmonized global risk management program into Site Quality Management System.
* Support integration of Quality Risk Management as it relates to data governance and GMP records.
* Support execution of risk assessments, risk control, risk communication and risk review.
* Support maintenance of site risk register.
* Provide risk management & data integrity training on site as required.
* Support the Site Quality Risk Management Council governance process.
* Represent organisation at Industry forums.
* Support DI GEMBA program within site.
* Support investigations from a QRM and DI perspective as required.
* Support Inspection Readiness, Hosting & Response activities as required.
Qualifications
In order to excel in this role, you will more than likely have:
* Minimum degree or post-graduate qualification (Science/ Pharmacy/ Engineering).
* 5 years’ experience in the pharmaceutical or biologics industry.
* Understanding and practical application of GMP standards and regulations.
* Strong working knowledge of laboratory, manufacturing and supporting computerised systems, and associated business processes.
* Proven record of influencing change.
* Skilled supporting cross-functional investigations.
* Analytical problem-solving skills.
As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, please apply today.
Employee Status: Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements: Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date: 03/7/2025
Requisition ID: R336433
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