Documentation Specialist

GMP Batch Documentation Specialist (m/f/d)

Make Every Batch Record Count as GMP Batch Documentation Specialist (m/f/d)

• Assignment period: 26 October 2026 – 30 June 2027
• Location: Schachen (LU)
• Employment type: Temporary placement via nemensis ag

Our client

Our client is an internationally active biopharma company specializing in clinical biologics manufacturing, known for its focus on operational excellence. As GMP Batch Documentation Specialist (m/f/d) , you join the Operational Excellence team.

Your tasks

• Batch record review: You review executed batch records (USP, DSP, weighing & dispense, solution/media prep) for ALCOA+ and GDP compliance
• Material tracking: You check executed PI sheets in COMET/SAP and verify planning BOMs for material tracking
• Quality support: You identify documentation gaps or errors and coordinate resolution with production teams
• Process documentation: You support the creation of batch record templates with Process Operations and Quality
• Deviation support: You support deviations, corrections and investigations and ensure GMP-compliant archiving

Your profile

• Education: Bachelor's degree or equivalent experience in life sciences, biotechnology, engineering or related field
• Experience: Hands-on experience in a GMP-regulated manufacturing environment, ideally within biologics
• Documentation know-how: Practical know-how in batch record review or manufacturing documentation
• GDP: Solid understanding of GDP principles
• Systems: Experience with paper-based and/or Electronic Batch Records (EBR)
• Languages: Very good command of German and English

What nemensis offers you

• Nemensis AG is your specialized recruitment partner in the Life Sciences sector, based in Basel
• Comprehensive guidance and support throughout the application process provided by our consultants
• Access to an extensive client network and exciting positions across North-Western Switzerland
• Fast and straightforward entry through individual guidance and advice during the application process

Ready for your next step?

At nemensis ag, we've connected thousands of candidates with their dream job. What can we do for you and your career today? Get in touch about the GMP Batch Documentation Specialist (m/f/d) position in Schachen (LU) – we're looking forward to hearing from you!