Technical Document Supervisor
Technical Document Supervisor
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
We are looking for a Technical Document Supervisor to join our MSAT function based at our Manufacturing site in Slough, UK. The incumbent will generate and revise documentation for GMP manufacturing to ensure technical accuracy and GMP compliance. The role will be to provide technical support to develop the required process documentation in collaboration with internal customers and will act as a trainer and will start to mentor other team members.
- Independently manage the creation of 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
- 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, use of DMS, documentation procedures and documentation best practice and provide assistance, support and training to others during routine document revision
- MSc, BSc or HND / HNC within relevant subjects or demonstrated equivalency
- Experience of editing and workflow management of tasks in DMS for batch records, process descriptions and product specifications
- Able to independently write batch documentation to support new product campaigns. Identifies, understands and communicates potential impact of changes to other functions in a timely manner
- Able to manage changes throughout the document / change lifecycle from document submission to effective state with minimal errors
- Good working knowledge of Manufacturing operations to allow independent drafting of documents
- In depth knowledge and awareness of the Manufacturing schedule and understanding of the impact to on time delivery of schedule changes
- Good interpersonal and organizational skills with ability to work within a cross functional team.
- Able to identify and act with own initiative on situations which require escalation, can recognize an abnormal or potentially impacting event and will routinely escalate to appropriate levels of attention
- Proactively offer suggestions to supervisor, manufacturing or technical owners on process improvements or scheduling issues
- Ability to internally communicate documentation updates to other affected departments
- Proven ability to deliver to deadlines
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.