About the CompanyThrough the work that we do, the team at Deciphex helps pharma to accelerate the process of essential drug development and helps patients to get timely and accurate diagnosis.
Founded in Dublin in 2017, Deciphex has scaled rapidly to a team of over 190 people and counting who are providing software solutions to address the pathology gap in research pathology and clinical areas.
We have offices in Dublin, Exeter, Oxford, Toronto, and Chicago and are expanding our team throughout the world.
We are software developers, clinical specialists, AI engineers, operations professionals and so much more, all working as one team to support our customers and patients.
Our team culture is built on trust.
We give our team the space they need to deliver results and the environment to ensure they can enjoy doing it.
We are looking for highly motivated individuals who are excited to take on challenges and value making a difference in their day-to-day work.
This is a unique opportunity to make a difference in the emerging Digital Pathology field.
Read more about Deciphex here. About this Role (Responsibilities):Collaborate with clients on projects to validate the Patholytix Preclinical SaaS for regulated intended useDevelop and maintain Validation and Test Plans, aligned with the overall project plan for a customer environmentProvide input to the development of realistic project schedules and document trackersManage customer-facing deliverables of our Software Development LifeCycle (SDLC)Ensure Change Control Summary Reports are delivered to clients in a timely manner post-software releaseWork as part of a cross-functional team to identify and implement procedural controls to mitigate issues found during testingIdentification and resolution of any issues (process or software) that may cause Regulatory scrutiny for our validated clientsProvide guidance, review and oversight for all CSV documentation within DeciphexWork closely with validated clients to navigate their Change Control processes when upgrading between versions of the Patholytix Preclinical platformAbout You (Skills and Experience):Bachelor's degree (or higher) in a relevant disciplineMinimum of 5 years' experience in a similar role delivering validated IT solutions, ideally in the Biotech or Pharmaceutical industry or other regulated environmentsMinimum of 2 years of experience working in a GxP environmentExpert knowledge of GAMP5Experience in the following is essential:GxP computer validationCFR 21 Part 11, CFR 21 Part 58IQ, OQ, PQ, UAT / SATStrong Project Management skillsExperience in or working under a regulated environment or any of the following considered a distinct advantage:CFR 21 Part 820ISO 13485Experience with AGILE and SCRUMYou will have shown leadership skills in previous positions and are keen to develop these skills further.You bring a sense of urgency to the work that you do and are able to execute on tasks by using your initiative.You enjoy innovating and bringing new ideas to the table.You like to have autonomy in your role and the independence to manage your own time and workload.You are highly collaborative and enjoy working with lots of different teams and people.You have great written and oral English language skills.What are the benefits of working with Deciphex? Competitive salary with performance-based annual increments.Healthcare benefitsCompetitive annual leaveA true sense of meaning in your work by contributing to better patient outcomes.The opportunity to work alongside a world-class high-performing team in a hyper-growth startup environment.A chance to work on exciting, challenging, and unique projects.Regular performance feedback and significant career growth opportunities.A highly collaborative and supportive multicultural team.Deciphex is an equal opportunities employer and we are committed to the principle of equality.
All qualified applicants will be considered for employment without regard to age, race, religious beliefs, political views, gender identity, affectional or sexual orientation, national origin, family or marital status (including pregnancy), disability, membership of the travelling community or any other classification protected by applicable law.
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