Description
MBR Designer to be based in Swindon on an initial 6 Month contract. Experienced in moving MBR Design.
Job Title - MBR Designer
Location - Swindon
Rate - £ 360 per day
Duration - 6 months
Key responsibilities:
- 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
Candidates should submit CVs in the first instance. Mike Tripp