* Onsite role. Some remote working possible but role is designated as onsite and typically 4 days per week. You should expect the first 3 to 6 months will be fully onsite
* Permanent or Contractor opportunity
Role Brief
The main focus of this role is to ensure that software validation is carried out in compliance with site/global policies and SOPs. You will work with technologies such as C#, Microsoft 365 and SQL amongst others. Quality experience is required in some of these areas or related software technologies. Coding experience in these areas is not an essential requirement but software quality experience is essential You will also ensure that best software validation practices are followed providing assurance that the system conforms to both GMP and technical requirements. Other areas of responsibility include providing software quality leadership to IS project teams with existing Project Managers, CSV and technical team members and providing quality engineering support to a wide portfolio of sitewide IS projects.
Skills Brief
* Strong Quality focus to ensure patient safety and product quality.
* Software quality experience with technologies such as C#, Microsoft 365 and SQL are ideal - coding experience is not a necessary requirement but is advantageous.
* Experience in a Medical Devices or a related regulated environment is essential. Only candidates with experience in Medical Devices, Pharma or Life Sciences will be considered at this time.
* Strong focus on continuous improvement using sound, systematic problem solving techniques.
* Strong collaboration and team working ethic.
* Excellent spoken and written English.
Person Brief
The ideal candidate will have strong experience in a similar Software Quality, Validation or other related role in Medical Devices, Pharma or Life Sciences and have a proven track record in GMP (Good Manufacturing Practice) environments.
The chosen individual must have:
* An IT background with experience in software quality and validation
* Strong general software capabilities
* Strong information and operational technology knowledge
* Process/Software validation experience
* Ambitious and self-motivated
* First class communication and relationship building skills
The role is based in Galway and is designated onsite and the chosen candidate will work a minimum of 4 days per week onsite. Therefore you must be currently living in the local area or be willing and able to relocate to the area in a reasonable time frame.
About NNIT
NNIT is a publicly listed company that specializes in IT solutions to life sciences internationally, and to the public and enterprise sectors in Denmark. We focus on high complexity industries and thrive in environments where regulatory demands and complexity are high. We advise on and build sustainable digital solutions that work for the patients, citizens, employees, end users or customers. NNIT consists of group company NNIT A/S and subsidiaries SCALES, Excellis Health Solutions and SL Controls. Together, these companies employ more than 1,800 people in Europe, Asia, and USA.
We celebrate diversity and are committed to creating an inclusive environment for all employees. All candidates are encouraged to apply for the given job regardless of their gender, age, religious beliefs, sexual orientation, national and social origin, political opinion, disability, race, skin colour, and ethnic origin.
In the interest of fostering a fair and unbiased recruitment process, we kindly request candidates to refrain from including their pictures in their applications.
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