GMP Documentation Specialist (m/w/d)

pWe 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. /p pThe GMP Documentation Specialist supports clinical biologics manufacturing by performing operational review of executed batch records and ensuring documentation supports ALCOA+ standards and GMP expectations. /p pThe 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). /p pThis position works closely with shop floor teams, manufacturing SMEs, and Quality while remaining fully embedded in Manufacturing. /p h3Key Responsibilities /h3 ul liPerform operational review of executed batch records for clinical biologics manufacturing, including: /li liUpstream Processing (USP) /li liDownstream Processing (DSP) /li liWeighing Dispense (WD) /li liSolution preparation (buffers, media) /li liReview paper-based batch records and EBR for alcoa+, data integrity, and GDP compliance /li liReview executed PI sheets in COMET (SAP) to ensure material tracking compliance and identify gaps or inconsistencies in planning BOMs /li liIdentify documentation gaps, errors, or inconsistencies and coordinate timely resolution with manufacturing teams /li liSupport right-first-time execution and continuous improvement of documentation practices /li /ul h3Documentation Creation Lifecycle Support /h3 ul liSupport the creation, maintenance, and update of batch record templates (paper and EBR) in collaboration with Process Operations, Tech Transfer, Process MES, and Quality /li liContribute to the creation, revision, and periodic review of manufacturing SOPs, work instructions, and forms /li liSupport implementation of documentation updates into manufacturing operations /li /ul h3Deviation Correction Support /h3 ul liSupport documentation-related deviations, corrections, and clarification activities /li liProvide input and supporting documentation for deviation investigations related to manufacturing records /li /ul h3Document Handling Archiving /h3 ul liIssue and control floor copies of approved batch records and manufacturing documents /li liSupport GMP-compliant archiving, retention, and controlled destruction of manufacturing documents in accordance with procedures /li liEnsure traceability and version control of manufacturing documentation throughout the document lifecycle /li /ul h3Required Qualifications /h3 ul liBachelor's degree or equivalent experience in life sciences, biotechnology, engineering, or a related field /li liExperience working in a GMP manufacturing environment, preferably biologics /li liHands-on experience with batch record review, manufacturing documentation, or shop-floor support /li liSolid understanding of GDP principles /li liExperience with paper batch records and/or Electronic Batch Records (EBR) /li /ul h3Preferred Qualifications /h3 ul liExperience in clinical manufacturing environments /li liFamiliarity with USP / DSP operations /li liExperience with WD and solution/media preparation documentation /li liExposure to MES / EBR systems (e.g. PAS-X, Syncade) /li /ul h3Key Skills Competencies /h3 ul liStrong attention to detail and structured working style /li liAbility to work cross-functionally with Process Operations, Tech Transfer, Process MES, and Quality /li liStrong written documentation and technical writing skills /li liProactive mindset with focus on process robustness and continuous improvement /li liStrong German and English language skills required for clear manufacturing communication and preparation, review, and maintenance of GMP-relevant documentation /li /ul h3Aditional informations : /h3 pTemporary contract : 26/10/2026 until 30/06/2027 /p pOnsite role /p #J-18808-Ljbffr