Quality Systems Expert

We are seeking a Quality Assurance Specialist to join our team. This individual will be responsible for ensuring the quality of our products and processes.

The Quality Assurance Specialist will collaborate with manufacturing and engineering functions to drive quality awareness, facilitate Good Manufacturing Practices and implement improvements to ensure product quality.

• Implement and monitor key quality indicators within the manufacturing processes to identify unexpected events and preventative measures in order to ensure continued product quality.
• Conduct checks and reviews of manufacturing operations to monitor factors which may affect product quality.
• Review and evaluate all internal executed batch records to facilitate disposition of product for Batch release
• Review externally manufactured product documentation
• Responsible for the Incoming Materials Testing Laboratory and site retains process.
• Completing final QA release on all incoming components to site.
• Managing the Incoming Components Team
• Participate in site commissioning and qualification program
• Review and participate in all deviations and changes to manufacturing operations to ensure appropriate investigation and assessment carried out and actions implemented and monitored.
• Support complex site and 3rdparty investigations, present issues to the QP in clear and concise manner
• Management of On Hold & Reject lists for the site
• Ensure continued product quality through the Quality System by:
• Support 3rd party activities including but not limited to the following:
• Product launch (MDR site of QP release, MDR acting as MAH oversight & market extensions)
• Review of changes from 3rd parties, generate MDR Change Control and work with Regulatory to understand impact to dossier
• Generate MDR PQR based on PQR provided by 3rd Party – work with 3rd Party to resolve any issues
• Prepare documents to support regulatory submissions e.g. QP declaration, Technical Agreements etc.
• Able to build good communication with 3rd Parties and be point of contract during product launch and commercial activities
• Maintaining oversight of on-site/3rdPartyoperations
• Participate in self-inspections.
• Use of Quality Risk Management to ensure manufacturing operations are adequate.
• Support operation of the site Training system, including preparing and presenting relevant training material, as required.
• Keep abreast of regulatory initiatives and new guidance/requirements
• Ensure compliance with appropriate regulatory guidance documents, while driving improvements in product and process quality
• Support and execute any other duties as assigned

The ideal candidate will possess the following qualifications and skills:

• Educated to degree level with 3+ years industry experience.
• Working knowledge of EU & US regulatory requirements.
• Experience in designing and implementing quality systems and/or a start-up an advantage.
• Experience in or knowledge of inhalation dosage forms an advantage.
• High proficiency in Microsoft Word/Excel/PowerPoint/MS Project etc.
• Proficiency in electronic systems/databases such as documentation, Trackwise, SAP etc.
• Good team working and strong communication skills across functions and organization.
• An ability to work flexibly in a changing environment. Good attention to detail and priority management essential.
• Flexibility to learn new skills and take on new tasks and responsibilities.
• The ability to work under pressure to demanding schedules is important, as is the ability to work on one's own initiative.

We are looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Educated to degree level with proven industry experience
• Working knowledge of EU & US regulatory requirements
• Experience with Investigational Medicinal Products manufacturing, an advantage
• Experience in or knowledge of inhalation dosage forms an advantage.
• Good team working and strong communication skills across functions and organization.
• Experience in people management preferred, but not essential

We welcome applications from diverse candidates who share our values of Innovation, Collaboration, Sustainability and Diversity. We offer a competitive salary, benefits package and opportunities for professional development. If you are passionate about delivering quality results and making a difference, please apply now