Description
MBR Designer - Werum PAS-X - Swindon - £340 per day - 6 months
MBR Designer is required for a leading pharmaceutical technology business based in Swindon. Hands on experience in Werum PAS-X is essential.
Requirements
- Gathering requirements for a MBR for a new product
- Liaising with various product (operations, validation) experts and subject matter experts to determine the requirements for the new MBR
- Creating a standard set of electronic work instructions to support site implementations which can be re-used at strategic manufacturing sites to support consistent, repeatable and compliant manufacturing process and an efficient technology transfer model
- Designing and developing State Diagrams in MES
- Determining updates for Master Data, State Diagrams, Equipment management
- Design and creation of complex MBR for Weighing & Dispensing, Solid Bulk Manufacturing and Packaging processes
- Site specific requirement analysis for each of the above processes and convert them in to Batch Records
- Validation of the created MBRs for site deployment
- Providing status updates to the Project Manager on a day to day basis on progress, issues and risks.
- Support execution of OQ w.r.t various interfaces like ERP, Deviation Management
- Work with product vendor on product related issues during upgrade
- Lead and guide QA Lead and Test ( Validation)engineer and provide guidance on MBR related issues
- Troubleshoot and defects resolution during validation of Master Batch Records
- Strong Pharmaceutical, Bio Tech, Manufacturing and Shop Floor Order processes knowledge to convert the site requirements in to Batch Records
If you are on the lookout for your next contract position then contact (see below) for more information.
MBR Designer - Werum Pas-X - Swindon - £340 per day - 6 months