At Sekisui Diagnostics, we help improve patient outcomes by doing what we've always done – focusing on innovating and developing highly accurate diagnostics tests, reagents and systems. In recent years, social and consumer needs for medical care have been diversifying in line with dramatic transformations in the global medical environment. We will continue to embrace change and challenge new frontiers so that we can create unique, high-quality products and services that will leave our customers truly satisfied. With worldwide state-of-the-art manufacturing facilities and an international sales and distribution network, we are a solid partner for healthcare professionals, distributors, and manufacturers around the world. Our global capabilities allow us to meet the specific needs of our wide range of customers - and customize solutions at both a regional and product level.
The QA team is looking to appoint a QA Documentation Specialist reporting to the QA Documentation Manager. This is a part time position (21 hours per week Mon-Wed). You will be involved in various documentation activities as described below.
- To prepare documentation using appropriate computer software.
- To circulate documentation for review/approval and training using the online documentation system.
- To provide support for users of the online documentation system.
- To prepare documentation for batch folders.
- To archive/retrieve quality records from the onsite storage area.
- To author relevant documents within the department.
- To assist in the release of information and data in response to requests.
- To perform training on quality issues as and when required.
This is a role that requires effective interaction with most functional areas. In particular it is important to establish a good working relationship with others in the Quality Assurance department as well as staff from QC, Manufacturing, Logistics, Engineering & Maintenance, Technical Operations, Commercial and IT.
Knowledge, Skills and Experience Required:
Minimum of English Language GCSE
Understanding of ISO 9001 Quality System
QA Documentation experience in a cGMP environment
Extensive knowledge of Word e.g. formatting, tables, images, etc.
Use of Microsoft Office including Excel, Access and Powerpoint
Sekisui offers a competitive compensation and benefits package
Thank you for your interest in this position. Only those applicants selected for an interview will be contacted.