<p>For one of our clients, a world-leading pharmaceutical company, we are seeking a QC CSV Business Specialist.</p><p>General Information:</p><ul><li>Start Date: ASAP</li><li>End date: 18.12.2026</li><li>Workplace: Bern</li><li>Workload: 100%</li><li>Home Office: no, 100% onsite</li><li>Working Hours: Standard</li></ul><p>Tasks & responsibilities:</p><ul><li>Computer-based applications expertise with practical experience across regulated (GxP) environments</li><li>Computerized System Validation (CSV): risk-based validation planning (URS/FS/RA/TP/TRL), objective evidence collection, deviation handling, and acceptance packets</li><li>GxP Archiving & Data Integrity: lifecycle archiving methods, retention/disposition, strategies, and integrity controls aligned to ALCOA+</li><li>Hands-on archiving execution (structured instrument databases and unstructured file systems) with Computerized System Validation (CSV) rigor (21 CFR Part 11, EU Annex 11, ALCOA+)</li><li>Structured Instrument Systems (DB-backed): Chromeleon and similar CDS/LIMS or instrument data stores - schema assessment, evidence capture, export/read-back planning</li><li>Unstructured/File-Based Archives: high-volume imaging/scanning, hash-based integrity, chain-of-custody, indexing for rapid eDiscovery/QA retrieval</li><li>Validation-ready capture of audit trails, metadata, and read-back capability</li><li>Suited to stand up a repeatable “archiving factory” while maintaining audit-ready evidence</li><li>Lead in Data Integrity initiatives</li><li>Lead in decommissioning qualified/validated equipment and systems through Change Control procedures</li><li>Lead in electronic archiving of computerized systems</li><li>Execute equipment lifecycle activities such as periodic audit trail and user access reviews, calibration and maintenance tasks if needed</li><li>Coordinate & manage the timely and effective completion of investigations, change controls and CAPA’s related to equipment activities</li><li>Coordinate and drive projects regarding equipment and automated systems within the QC labs department</li><li>Additional tasks can be assigned by the QCSE Manager</li></ul><p>Requirements / Qualifications:</p><ul><li>Bachelor or advanced degree in Chemistry, Biochemistry, Pharmacy, applied Sciences or relevant scientific discipline or equivalent combination of education, training and experience.</li><li>Deep technical know-how of QC Lab equipment (computerized and non-computerized) and corresponding system life cycle activities (commissioning, qualification, validation, maintenance, decommissioning)</li><li>Sound experience in computerized system validation (CSV) in a GMP environment and good knowledge of related regulatory requirements in the life science industry (GAMP 5, 21 CFR part 11)</li><li>Skilled in leading QC equipment related investigations, experienced in Root</li><li>Cause Analysis tools (e.g. 5 Why, Fishbone, Kepner-Tregoe) and technical writing</li></ul><p>Skills & competencies:</p><ul><li>Self-dependent way of working and taking ownership of assigned tasks to plan and deliver according to agreed timelines.</li><li>Strong analytical thinking and problem-solving ability</li><li>Excellent communication and teamwork skills</li><li>Ability to simultaneously support multiple duties and assignments and prioritize accordingly</li><li>Good language skills in English, written and spoken</li><li>Excellent writing skills for scientifically sound technical documents, instructions, protocols and reports.</li></ul><p>Sounds interesting? Apply now – we’re looking forward to receiving your applications!</p>