GMP Documentation Specialist (m/w/d)

Are you passionate about quality, precision, and working in a GMP-regulated environment?

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 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.

Key Responsibilities

Executed Batch Record Review:

• Perform operational review of executed batch records for clinical biologics manufacturing, including:
  • 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

• Support 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

• Support 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 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 focus on process robustness and continuous improvement
• Strong German and English language skills required for clear manufacturing communication and preparation, review, and maintenance of GMP‑relevant documentation

Additional information:

• Contract duration: This is a 12-month contract position, planned to start in July, with the possibility of extension. 1.07.2026 till 31.06.2026
• Type of employment: Temporary staffing
• Location: Schachen
• Working type: onsite

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