<p>For one of our clients, an international pharmaceutical company, we are seeking a GMP Documentation Specialist.</p><p>General Information:</p><ul><li>Start date: 01.07.2026</li><li>End Date: 30.06.2027</li><li>Workplace: Schachen, Luzern</li><li>Home office: No, 100% onsite</li><li>Workload: 100%</li><li>Working hours: Standard</li></ul><p>About the work:</p><p>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.</p><p>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).</p><p>This position works closely with shop floor teams, manufacturing SMEs, and Quality while remaining fully embedded in Manufacturing.</p><p>Tasks & Responsibilities:</p><p>Executed Batch Record Review</p><ul><li>Perform operational review of executed batch records for clinical biologics manufacturing, including:</li><li>Upstream Processing (USP)</li><li>Downstream Processing (DSP)</li><li>Weighing & Dispense (W&D)</li><li>Solution preparation (buffers, media)</li><li>Review paper-based batch records and EBR for alcoa+, data integrity, and GDP compliance</li><li>Review executed PI sheets in COMET (SAP) to ensure material tracking compliance and identify gaps or inconsistencies in planning BOMs</li><li>Identify documentation gaps, errors, or inconsistencies and coordinate timely resolution with manufacturing teams</li><li>Support right first time execution and continuous improvement of documentation practices</li></ul><p>Documentation Creation & Lifecycle Support</p><ul><li>Support the creation, maintenance, and update of batch record templates (paper and EBR) in collaboration with Process Operations, Tech Transfer, Process MES, and Quality</li><li>Contribute to the creation, revision, and periodic review of manufacturing SOPs, work instructions, and forms</li><li>Support implementation of documentation updates into manufacturing operations</li></ul><p>Deviation & Correction Support</p><ul><li>Support documentation-related deviations, corrections, and clarification activities</li><li>Provide input and supporting documentation for deviation investigations related to manufacturing records</li><li>Document Handling & Archiving</li><li>Issue and control floor copies of approved batch records and manufacturing documents</li><li>Support GMP compliant archiving, retention, and controlled destruction of manufacturing documents in accordance with procedures</li><li>Ensure traceability and version control of manufacturing documentation throughout the document lifecycle</li></ul><p>Requirements:</p><ul><li>Bachelor’s degree or equivalent experience in life sciences, biotechnology, engineering, or a related field</li><li>Experience working in a GMP manufacturing environment, preferably biologics</li><li>Hands-on experience with batch record review, manufacturing documentation, or shop floor support</li><li>Solid understanding of GDP principles</li><li>Experience with paper batch records and/or Electronic Batch Records (EBR)</li></ul><p>Nice to haves:</p><ul><li>Experience in clinical manufacturing environments</li><li>Familiarity with USP / DSP operations</li><li>Experience with W&D and solution/media preparation documentation</li><li>Exposure to MES / EBR systems (e.g. PASX, Syncade)</li></ul><p>Key Skills & Competencies</p><ul><li>Strong attention to detail and structured working style</li><li>Ability to work cross functionally with Process Operations, Tech Transfer, Process MES, and Quality</li><li>Strong written documentation and technical writing skills</li><li>Proactive mindset with focus on process robustness and continuous improvement</li><li>Strong German and English language skills required for clear manufacturing communication and preparation, review, and maintenance of GMP relevant documentation</li></ul><p>Sounds interesting? Apply now – we’re looking forward to receiving your applications!</p>

<p>Spécialiste Support Production / Déviations (USP/DSP</p><p>Entreprise : Incyte (Yverdon-les-Bains)<br />Type de poste : Temporaire (jusqu'à la fin de l'année)<br />Horaires : De journée<br />Localisation : Nord Vaudois</p><p> </p><p>Pour le site de production pharmaceutique de notre client, nous recherchons un Spécialiste Support Production.</p><p> </p><p>Vous serez l'expert des opérations et de la qualité.<br />Votre bureau ? Le shopfloor.<br />Votre quotidien ? Être au plus près des bioréacteurs (USP), des colonnes de chromatographie, des systèmes UFDF et de nanofiltration pour garantir que chaque lot produit est une réussite.</p><p> </p><p> </p><p>Responsabilités</p><ul><li>Spécialiste production : Lorsqu'un écart survient en plein milieu d'une culture cellulaire ou d'une purification, vous êtes sur place. Vous enquêtez en direct avec les opérateurs, analysez l'impact technique et proposez des solutions immédiates.</li><li>Maître de la Conformité Opérationnelle : Vous pilotez les déviations et les CAPA. Votre objectif ? Comprendre le "pourquoi" (Root Cause) pour que le problème ne revienne jamais.</li><li>Expert Technique (SME) : Vous participez à l'amélioration continue des équipements et des processus. Lors des audits, c’est vous qui présentez avec fierté la robustesse des investigations.</li><li>Amélioration Continue : Vous révisez les Batch Records et les SOP pour les rendre plus simples, plus sûrs et plus efficaces pour les équipes de fabrication.</li></ul><p> </p><p> </p><p>Profil</p><ul><li>Formation : Du CFC (technologue en production de chimie/biotech) au Master (Ingénieur Biotech/Pharma). C’est votre expérience et votre compétence technique qui priment.</li><li>Expérience : Vous avez au moins 3 ans d'expérience en production Biotech (obligatoire). Vous connaissez le jargon USP/DSP et la réalité des zones classées.</li><li>Savoir-être : Vous êtes "moteur". Vous n’attendez pas qu’on vous donne une tâche, vous allez au-devant des problèmes. Vous savez communiquer avec pédagogie auprès des opérateurs et avec fermeté auprès de la Qualité.</li><li>Langues : Français courant. L’anglais (niveau B2) est indispensable pour les rapports de déviations.</li></ul>

Join a fast-growing Bioplant in Yverdon-les-Bains during a pivotal expansion phase. We are seeking a QA QC Expert to ensure the highest quality standards for our Drug Substances and Raw Materials.<br /><br />Responsibilities<ul><li>Batch Disposition: Collect and review all records for Drug Substance (DS) and Drug Product (DP) release; chair weekly disposition meetings.</li><li>QA Oversight of QC: Provide day-to-day quality guidance to the lab, approving specifications, analytical methods, and sampling plans.</li><li>Operational Quality: Lead QA activities for method transfers/validations and support the commissioning of new lab equipment.</li><li>Quality Events: Manage Deviations, OOS (Out of Specification), OOT (Out of Trend), and Change Controls.</li><li>Project Support: Contribute to the implementation of raw material testing and new sterility tests.</li><li>Systems: Review LIMS master data changes and support computerized system integration.</li></ul><br />Profile<ul><li>Education: Academic degree in Biotechnology, Pharmacy, Bioprocessing, or a related field.</li><li>Experience: Minimum 5 years in a GMP environment.</li><li>Industry Expertise (Mandatory): Solid experience in Biotech or Vaccines (Antibodies/Proteins). </li><li>Technical Hybrid: Strong background in Quality Control (hands-on or oversight) transitioned into QA.</li><li>Methods: Demonstrated experience in analytical method validation and transfer.</li><li>Systems (Plus): Experience with LIMS (configuration or data review) is a significant advantage.</li><li>Soft Skills: Pragmatic decision-maker, team player, and excellent communicator.</li><li>Languages: Fluency in English and French is required.</li></ul><br /><br />Profiles from Medical Devices or Solid Dosage will not be considered.