Document Management Specialist Consultant
Province of Brussels, Belgium
Are you looking for a new challenge and you want to work as a Document Management Specialist? You want to provide business and technical expertise and drives for excellence?
This assignment is for you!
To undertake this role, the Document Management Specialist has a strong understanding of the core business activity of Early Solutions, as well as operational skills in order to effectively engage with varied stakeholders and ensure the broad remit of the role.
The role ensures organizational efficiency and compliance with national or international regulations.
In addition the role contributes to business process improvements initiatives across Early Solutions in order to streamline, simplify, standardize processes to increase quality and enhance operational efficiency.
- Maintains an efficient documentation of all Quality Management Systems (QMS) in the business scope in order to ensure high quality level of documents such as SOPs, internal guidelines, personal documentation, chemical and environmental safety documents, training plans and trainings, electronic laboratory notebooks;
- Participates to the deployment of databases related to Controlled Documents (ECMS), training (ELMS);
- Ensures compliance with GLP, GCP, ICH M7, EMEA, ECHA, Eudralex regulations and guidelines, internal guidelines and policies;
- Participate in and respond to the actions of internal and external inspections and audits to ensure that actions are tracked and followed up on;
- Harmonizes the content of training plans across Early Solutions;
- Networks, connects and builds relationships with key internal support stakeholders (Quality Assurance, Development Science, Biological Formulation Development);
- Technical Support for Early Solutions users related to ECMS, ELMS and ELN databases.
- Proven experience under GxP (GLP, GCP) regulations
- Proven experience in ECMS, ELMS and ELN
- Experience of working in pharma industry, knowledge of pharmaceutical development processes and scientific deliverables
- Bachelor degree (Life Sciences, Documentation, Quality Assurance)
- Rigor and precision
- Good planning and organizational skills
- Priority management, ability to work on multiple tasks and objectives
- Analytical and process minded
- Extensive computer skills
- Customer and quality focused
- Fluent in both English and French
- Service management, problem-solving, solution driven
- Team spirit
This description matches your profile and expectations?