We are currently looking for 2 x Scientific Document Editors to join our Manufacturing Science and Technology (MSAT) team. This is a permanent position based out of our Slough facility.
Working within the MSAT function the primary purpose of this position is to generate and revise documentation for GMP manufacturing to ensure technical accuracy and GMP compliance. The role will be to provide technical editing and writing support to develop the required process documentation in collaboration with internal customers.
- Independently create new documents and revise GMP documents for complex technical changes according to documented procedure to maintain accuracy and compliance with other procedures
- Use and maintenance of the Documentation Management System (DMS) according to documented procedure
- Responsible for the production and processing of batch documentation according to standard timelines, coordinate review, approval and issuance ensuring availability for use in Manufacturing per production schedule.
- Monitor progress of document creation and communicate with relevant parties where appropriate in order to resolve potential issues in a timely manner
- Responsible for the timely management and closure of required documentation quality records e.g. DCFs, Tasks and CAPAs
- Assist with the Creation and coordination of Change controls and completion of change assessments in Trackwise in conjunction with internal Lonza donors
- Working with others, actively contributes to the proposal, development and implementation of required manufacturing procedures and work instructions
- Maintenance of GMP document templates and document style and format standards
- Advise on document style and content, using Lonza's Document Management System best practice.
What we need you to have:
The successful candidate will have experience of editing and workflow management ideally gained within the pharmaceutical environment. The candidate would preferably have knowledge or experience of either Upstream or Downstream manufacturing processes.
You will also need:
- To be able to independently write scientific documentation.
- To have excellent attention to detail together with good interpersonal qualities
- To be self-motivated and positive with a desire to develop technically in their area of expertise
- Materials Science