ABOUT THE COMPANY

Through 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 and more about our incredible team on our Careers Page here

REQUIRED SKILLS AND EXPERIENCE:

• Diploma or higher in a life science subject
• Experience working with an electronic documentation system is highly desirable.
• Knowledge of recognised quality guidance or standards
• Organised and diligent with activities
• Good team player and have the ability to work with various groups.
• Good time keeping skills and ability to meet timelines
• Proactive with improving document control and training process.
• Willing to learn and be proactive in developing skills & experience
• Experience with GLP regulations or software will be ‘a distinct advantage’

ROLE TYPE & LOCATION

• This role is remote based in Ireland or the UK.
• This role is full time, one year fixed term contract.

RESPONSIBILITIES:

• Responsible person for the electronic document control process. Manage and update the electronic Document Register and document control email box.
• Manage e-document control and training system for onboarding and offboard of employees
• Lead the process for generating new controlled documents and managing the periodic document review process.
• Distribute key printed policies and documents throughout the Deciphex business
• Liaise with pre-clinical and clinical software testing/development teams regarding document control for various product software releases projects.
• Review and prepare all controlled documents and registers ensuring document formatting is correct.
• DocuSign System User- process GxP documents and records for e-signatures.
• Maintenance of the document control library structure including managing access privileges to IMS files
• Provide Document Control support to Deciphex offices in Ireland, UK, US and other locations as required.
• Archiving of any paper documents and records.
• Complete all mandatory company training and job specific training required for the role, including ISMS, GLP, DocuSign, SDLC as applicable.
• Training of new hires in relevant document control and training processes
• Coordinate training activities, as required. This includes scheduling classroom training for mandatory company training
• Ensure training records are obtained and filed following completion of scheduled training.
• Record and monitor KPIs for the document control and training processes
• Proactively identify and implement process improvements in relation to IMS systems within Deciphex.
• Assist Quality Management in audit preparation activities.
• Support the progress of the audits for example act as a scribe, runner, document controller as required