Document Controller GMP
We are a medium size early phase Pharmaceutical CRO which require a Document Controller for the GMP Department after a recent expansion. You will need to be able to prioritise your own workload, meet tight schedules and business deadlines.
We are looking for a document controller with good knowledge of Sharepoint/Dropbox management systems, project compliance and procedures, preferably gained within a Chemistry/ Quality /Analytical environment.
- You will be the responsible for the control of GMP documents from initial writing, through revision, up to issuing of the documents for use.
- Receipt and logging of project documentation, maintaining document registers and numbering systems
- Managing the flow of documentation within the organisation, including workflow approvals, sign offs and revision/version control
- Distributing and Managing the flow of documentation via clients for review and signature
- Data Management and cleansing activities to ensure accuracy and completeness
- Providing an accurate and up-to-date status of the information/document flow whenever requested
- Regularly auditing company systems to ensure correct and accurate usage
- Copying, scanning and storing documents and retrieve as required
- Creating templates for future use
- Maintaining confidentiality around sensitive information and terms of agreement
- Preparing ad-hoc reports on projects as needed
- Assisting the Management Team in the production monthly report
- Strong competence using Microsoft Office including Sharepoint, Teams and Dropbox.
- Proficient with other MS Office software, Excel and Word etc.
- Knowledge of quality assurance processes applicable to document management
- Preferably experience of working within a GMP environment
- Proactive and assertive for chasing and expediting documents
- A “can do” motivated approach to problem solving
- A keen eye for detail with exceptional organisational skills
- An individual with a team mentality who is capable of collaborative working
- Ability to work in technical environment with conflicting priorities and constraint