**Job Title:** Quality Systems Specialist
This role is an exciting opportunity to make a significant impact on the quality of our products. We are seeking a skilled professional with expertise in quality systems and a passion for ensuring product excellence.
Key Responsibilities:
* Collaborate with manufacturing and engineering functions to drive quality awareness and facilitate Good Manufacturing Practices.
* Implement and monitor key quality indicators within the manufacturing processes to identify unexpected events and preventative measures.
* Conduct checks and reviews of manufacturing operations to monitor factors that may affect product quality.
* Review and evaluate internal executed batch records to facilitate disposition of product for Batch release.
* 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 3rd party investigations, presenting issues to the QP in clear and concise manner.
About Your Skills & Experience:
We're 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.
Benefits:
We offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.