Documentation Specialist m/f/d
This job offer is no longer available.
Lucerne, Switzerland |
Temporary Employment
The GMP Documentation Specialist supports clinical biologics manufacturing by performing operational review of executed batch records and ensuring documentation supports ALCOA+ standards and GMP expectations.
The role is part of the Operational Excellence team within Manufacturing Operations and focuses on right-first-time execution, documentation robustness, and efficient record lifecycle management across paper-based batch records and Electronic Batch Records (EBR).
This position works closely with shop floor teams, manufacturing SMEs, and Quality while remaining fully embedded in Manufacturing
Project title: Documentation Specialist m/f/d
Type of employment: Payroll
Industry: Engineering
Skills: Batch record review,Clinical,german
Project start: 01.07.2026
Project duration: 12 months
Location: Lucerne, Switzerland
Tasks:
Executed Batch Record Review
- operational review of executed batch records for clinical biologics manufacturing, including:
oUpstream Processing (USP)
oDownstream Processing (DSP)
oWeighing & Dispense (W&D)
oSolution preparation (buffers, media)
- paper-based batch records and EBR for alcoa+, data integrity, and GDP compliance
- executed PI sheets in COMET (SAP) to ensure material tracking compliance and identify gaps or inconsistencies in planning BOMs
- documentation gaps, errors, or inconsistencies and coordinate timely resolution with manufacturing teams
- right-first-time execution and continuous improvement of documentation practices
Documentation Creation & Lifecycle Support
- the creation, maintenance, and update of batch record templates (paper and EBR) in collaboration with Process Operations, Tech Transfer, Process MES, and Quality
- to the creation, revision, and periodic review of manufacturing SOPs, work instructions, and forms
- implementation of documentation updates into manufacturing operations
Deviation & Correction Support
- documentation-related deviations, corrections, and clarification activities
- input and supporting documentation for deviation investigations related to manufacturing records
Document Handling & Archiving
- and control floor copies of approved batch records and manufacturing documents
- GMP-compliant archiving, retention, and controlled destruction of manufacturing documents in accordance with procedures
- traceability and version control of manufacturing documentation throughout the document lifecycle
Qualifications:
- degree or equivalent experience in life sciences, biotechnology, engineering, or a related field
- Experience working in a GMP manufacturing environment, preferably biologics
- Hands-on experience with batch record review, manufacturing documentation, or shop-floor support
- Solid understanding of GDP principles
- Experience with paper batch records and/or Electronic Batch Records (EBR)
- Strong German and English language skills required for clear manufacturing communication and preparation, review, and maintenance of GMP-relevant documentation
Preferred Qualifications
- Experience in clinical manufacturing environments
- Familiarity with USP / DSP operations
- Experience with W&D and solution/media preparation documentation
- Exposure to MES / EBR systems (e.g. PAS-X, Syncade)
Reference number: 17442
Industry: Engineering
Project start: 01.07.2026
Duration: 12 months
Employment type: Temporary Employment
Contact
Tünde Verebélyi