A fantastic opportunity has arisen for a Senior Specialist, QP at our site in Brinny, Co. Cork. The QP will form active partnerships across all areas of the site, providing independent quality support, guidance and expertise to a diverse variety of functions and departments. The QP will model the Company Leadership behaviours and understand the MPS principles to drive a culture of continuous improvement building a High-Performance Organisation.
Bring energy, knowledge, innovation to carry out the following:
- Carry out the responsibilities of the Qualified Person as per the requirements of the respective EU Directive.
- Batch Record Review of drug substance.
- Review of QC Analytical and Microbiological data.
- QP Confirmation activities associated with the manufacture of drug substance batches as defined in regulations.
- Active participation at the Deviation Review Board, Site Quality Council and other relevant forums pertinent to product quality review.
- Champion the highest Quality and Compliance standards for the site.
- Champion Permanent Inspection Readiness for the site.
- Provides the site and network with ownership/expertise in the manufacturing division’s Quality Management Systems and/or Operational Quality, including but not limited to the following: Quality Notifications/Investigations; Change Management; environment monitoring programs; sterility assurance/low bioburden manufacturing; customer compliant investigations; recall/market actions.
- Uses knowledge to improve; Quality Systems and/or Operational Quality; drive the solution to complex problems; provide continuous improvement and execute tasks.
- Responsible for issuing/corresponding on regulatory communications and notifications as pertaining to the site and any materials manufactured within it.
What skills you will need:
In order to excel in this role, you will more than likely have:
- Degree or 3rd level qualification (Science, Quality).
- QP qualification.
- Desirable evidence of Continuous Professional Development.
- Preference for Lean Six Sigma Green Belt.
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. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.
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.
Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, please apply today.
