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 Area - home office possible
Start date: 08.01.2024
End date: 31.03.2024 - with extension

Main responsibilities

• MBR Design and Development: Create and modify Master Batch Records in the PAS-X Werum system, Version 3.x ensuring they accurately reflect the manufacturing processes.
• Validation and Testing: Validate the MBRs by conducting thorough testing to ensure they function correctly and meet all regulatory requirements. (Optional)
• Collaboration: Work closely with production, quality assurance, and other departments to gather necessary information and feedback for MBR development.
• Training and Support: Provide training and support to end-users, helping them understand how to use the MBRs effectively.
• Continuous Improvement: Continuously assess and improve MBRs and related workflows to increase efficiency, compliance, and product quality.
• Documentation: Maintain comprehensive documentation for all MBRs, including change histories, validation records, and user manuals.
• Compliance: Ensure that all MBRs comply with relevant industry standards, regulations, and internal SOPs.
• Issue Resolution: Quickly resolve any issues or discrepancies in MBRs, ensuring minimal disruption to manufacturing processes.
• Knowledge Sharing: Stay updated on industry best practices and share knowledge with the team to foster a continuous learning environment.
• Maintenance, troubleshooting, and optimization of MBR on Werum PAS-X systems to ensure maximum uptime and operational efficiency

Your skills:

• Bachelor's degree in a related field such as Biotechnology, Pharmacy, Engineering, or equivalent.
• Minimum of 5-8 years of experience on Werum PAS-X systems authoring Recipes and Modeling MBR's
• Proven experience in MBR development within the PAS-X system. (versions?) 3.X
• Strong understanding of GMP and other regulatory requirements in pharmaceutical or biotech manufacturing.
• Excellent attention to detail and strong problem-solving skills.
• Ability to work effectively in a cross-functional team environment.
• Strong communication skills, both written and verbal.
• Proficient in Microsoft Office and other related software.
• Ability to manage multiple tasks simultaneously and meet tight deadlines.
• Experience of the MES within the pharmaceutical or biotech industry.
• Fluent in German and English mandatory.

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.