QC CSV Business Specialist

For one of our clients, a world-leading pharmaceutical company, we are seeking a QC CSV Business Specialist.

General Information:

• Start Date: ASAP
• End date: 18.12.2026
• Workplace: Bern
• Workload: 100%
• Home Office: no, 100% onsite
• Working Hours: Standard

Tasks & responsibilities:

• Computer-based applications expertise with practical experience across regulated (GxP) environments
• Computerized System Validation (CSV): risk-based validation planning (URS/FS/RA/TP/TRL), objective evidence collection, deviation handling, and acceptance packets
• GxP Archiving & Data Integrity: lifecycle archiving methods, retention/disposition, strategies, and integrity controls aligned to ALCOA+
• 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+)
• Structured Instrument Systems (DB-backed): Chromeleon and similar CDS/LIMS or instrument data stores - schema assessment, evidence capture, export/read-back planning
• Unstructured/File-Based Archives: high-volume imaging/scanning, hash-based integrity, chain-of-custody, indexing for rapid eDiscovery/QA retrieval
• Validation-ready capture of audit trails, metadata, and read-back capability
• Suited to stand up a repeatable “archiving factory” while maintaining audit-ready evidence
• Lead in Data Integrity initiatives
• Lead in decommissioning qualified/validated equipment and systems through Change Control procedures
• Lead in electronic archiving of computerized systems
• Execute equipment lifecycle activities such as periodic audit trail and user access reviews, calibration and maintenance tasks if needed
• Coordinate & manage the timely and effective completion of investigations, change controls and CAPA’s related to equipment activities
• Coordinate and drive projects regarding equipment and automated systems within the QC labs department
• Additional tasks can be assigned by the QCSE Manager

Requirements / Qualifications:

• Bachelor or advanced degree in Chemistry, Biochemistry, Pharmacy, applied Sciences or relevant scientific discipline or equivalent combination of education, training and experience.
• Deep technical know-how of QC Lab equipment (computerized and non-computerized) and corresponding system life cycle activities (commissioning, qualification, validation, maintenance, decommissioning)
• 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)
• Skilled in leading QC equipment related investigations, experienced in Root
• Cause Analysis tools (e.g. 5 Why, Fishbone, Kepner-Tregoe) and technical writing

Skills & competencies:

• Self-dependent way of working and taking ownership of assigned tasks to plan and deliver according to agreed timelines.
• Strong analytical thinking and problem-solving ability
• Excellent communication and teamwork skills
• Ability to simultaneously support multiple duties and assignments and prioritize accordingly
• Good language skills in English, written and spoken
• Excellent writing skills for scientifically sound technical documents, instructions, protocols and reports.

Sounds interesting? Apply now – we’re looking forward to receiving your applications!