QC CSV Business Specialist

 

Our client, a dynamic global bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a QC CSV Business Specialist on a 7 month contract based in the Bern.

 

Main 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 (21CFR 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

 

Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required.
  • 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 noncomputerized) 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
  • 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
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