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 cancer patients get timely and accurate diagnosis.
Founded in Dublin in 2017, Deciphex has scaled rapidly to a team of over 100 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, Toronto and Chicago and are expanding our team throughout the world.
We are software developers, clinical specialists, artificial intelligence engineers, operations professionals and so much more, all working as one team to support our customers and patients.
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 to join our team!
About this Role (Responsibilities):
- Process owner 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 UK, US and other locations as required.
- Archiving of any paper documents and records.
- Monitor supplier management register for expiring/expired certificates and obtain new certificates as required.
- 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.
About You (Skills and Experience):
- Diploma or higher in a life science subject
- 3+ years experience in a similar role in a regulated life science industry (Pharma, Medical Device, IVD etc).
- Experience with delivering training is an advantage.
- Experience with GLP regulations or software will be ‘a distinct advantage.’
- Experience working with an electronic documentation system is highly desirable.
- Experience with a recognised quality guidance or standard such as GxP/GLP, ISO 13485 and/or ISO 9001 is an advantage.
- 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
What are the benefits of working with Deciphex?
- A 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 with.
- A chance to work on exciting and challenging unique projects.
- Regular performance feedback and future career opportunities.
- A flexible/ hybrid working model - most of our team work remotely and attend the office from time to time as required giving employees the autonomy to manage their own work life balance.
- A highly collaborative and supportive multi cultural 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.