MBR Modelling Specialist
MBR Modelling Specialist
Experis is the global leader in professional resourcing and project-based workforce solutions.
Overview of contract
On behalf of our client, a large IT Consultancy in Switzerland, we are looking for a Manufacturing Documentation Specialist in the pharmaceutical industry.
Location: Zürich - home office possible
Start date: 01.01.2024
End date: 31.03.2024 - with extension
Main responsibilities
* Gather and analyze requirements to create Manufacturing Batch Records (MBR), Good Manufacturing Batch Records (GMBR), and Equipment Specification Documents (ESP).
* Apply a comprehensive understanding of GxP (Good Practices), GAMP (Good Automated Manufacturing Practice), and 21 CFR regulations.
* Conduct thorough testing of created MBRs to ensure accuracy and adherence to industry standards.
* Contribute to the development and maintenance of a robust documentation system for manufacturing processes.
* Collaborate with cross-functional teams to ensure seamless integration of documentation requirements.
* Stay abreast of industry trends and regulatory updates related to manufacturing documentation.
* Drive continuous improvement initiatives to enhance the efficiency and compliance of manufacturing processes.
* Provide training and support to team members on documentation best practices and compliance standards.
Your skills:
* Familiar with SAP MES or PAS-X Werum is a must
* Possess expertise in material equipment, production unit, and master data management.
* Demonstrate strong knowledge of pharmaceuticals, biotech, and API manufacturing processes.
* Knowledge of GxP, GAMP, 21 CFR
* Fluent in English and German
If you are interested in this opportunity, we look forward to receiving your CV or if you have any questions, contact Kaixi Jia on +41 44 229 99 43 or Kaixi.jiawu(at)experis.ch
Check out all open positions at Experis at www.experis.ch
Due to Swiss work permit restrictions, we can only consider applications from Swiss nationals, EU citizens as well as current work-permit holders for Switzerland.
