GMP Documentation Specialist / GMP Documentation Specialistess

Job Opportunity: GMP Documentation Specialist (m/w/d)

We are currently seeking a detail-oriented GMP Documentation Specialist (m/w/d) to join our client’s Manufacturing Operations team in a dynamic, fast-paced biopharmaceutical environment. The GMP Documentation Specialist plays a crucial role in supporting clinical biologics manufacturing by performing operational reviews of executed batch records and ensuring that documentation aligns with ALCOA+ standards and GMP expectations. This position is part of the Operational Excellence team within Manufacturing Operations, focusing on right-first-time execution, documentation robustness, and efficient record lifecycle management across both paper-based and Electronic Batch Records (EBR).

Key Responsibilities

• Executed Batch Record Review:
  • Perform operational review of executed batch records for clinical biologics manufacturing, covering:
  • Upstream Processing (USP)
  • Downstream Processing (DSP)
  • Weighing & Dispense (W&D)
  • Solution preparation (buffers, media)
  • Review paper-based batch records and EBR for ALCOA+, data integrity, and GDP compliance.
  • Review executed PI sheets in COMET (SAP) to ensure material tracking compliance and identify gaps or inconsistencies in planning BOMs.
  • Identify documentation gaps, errors, or inconsistencies and coordinate timely resolution with manufacturing teams.
  • Support right-first-time execution and continuous improvement of documentation practices.
• Documentation Creation & Lifecycle Support:
  • Assist in the creation, maintenance, and update of batch record templates (paper and EBR) in collaboration with Process Operations, Tech Transfer, Process MES, and Quality.
  • Contribute to the creation, revision, and periodic review of manufacturing SOPs, work instructions, and forms.
  • Support implementation of documentation updates into manufacturing operations.
• Deviation & Correction Support:
  • Assist with documentation-related deviations, corrections, and clarification activities.
  • Provide input and supporting documentation for deviation investigations related to manufacturing records.
• Document Handling & Archiving:
  • Issue and control floor copies of approved batch records and manufacturing documents.
  • Support GMP-compliant archiving, retention, and controlled destruction of manufacturing documents in accordance with procedures.
  • Ensure traceability and version control of manufacturing documentation throughout the document lifecycle.

Required Qualifications

• Bachelor’s degree or equivalent experience in life sciences, biotechnology, engineering, or a related field.
• Experience working in a GMP manufacturing environment, preferably in 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).

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).

Key Skills & Competencies

• Strong attention to detail and structured working style.
• Ability to work cross-functionally with Process Operations, Tech Transfer, Process MES, and Quality.
• Strong written documentation and technical writing skills.
• Proactive mindset with a focus on process robustness and continuous improvement.
• Strong German and English language skills are required for clear manufacturing communication and preparation, review, and maintenance of GMP-relevant documentation.

Additional Information

Temporary contract: 26/10/2026 until 30/06/2027.

Onsite role.

Apply online using the form below. Only applications matching the job profile will be considered.