Freelance Consultant for Batch Record Review / MES (w/m/d)
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Western Austria, Austria |
Freelance
Freelance Consultant: Batch Record Review / MES | Freelance | Western Austria | Start: immediately | Duration: 6 months |
About the Project
Our client , is seeking two experienced GMP documentation specialists to cover peak demand. The project focuses on the meticulous processing and documentation of batch records in a highly regulated environment.
The work is performed under QA supervision and requires in-depth knowledge of SAP and, ideally, WERUM PAS, as well as a precise, GMP-compliant approach to reviewing batch records and the associated exceptions and plausibility checks.
Your Responsibilities
- Processing and documenting batch records in accordance with GMP standards
- Verifying exceptions for accuracy, completeness, and plausibility
- Process documentation of production processes (mixing operations, weighing processes, vessel transfers)
- Close collaboration with the QA team to ensure quality standards
Your Profile
- Extensive experience with Electronic Batch Records (EBR) and Manufacturing Execution Systems (user-side)
- Proficiency with Werum PAS-X is a plus; SAP is required
- In-depth understanding of GMP guidelines and pharmaceutical documentation
- Experience in process engineering and production documentation
- Very good command of German; English is a plus
- Precise and detail-oriented approach to work in a regulated environment
Project Details
- Project start: Immediate
- Project duration: 6 months (with an option to extend for an additional 6 months)
- Location: Western Austria (on-site)
- Workload: Full-time (100%)
Reference number: 17776
Industry: Biotechnology
Project start: Effective immediately
Duration: 6 months
Employment type: Freelance
Contact
Alexander Brzezowsky