Senior Quality Validation Analyst

Senior Quality Validation Analyst

Chemie / Pharma / Biotechnologie
  • Temporär - Vollzeit
  • Referenz : INT-029652
  • Teilen:


  • Region Basel
  • Art des Vertrags Temporär - Vollzeit
  • Tätigkeitssektor Chemie / Pharma / Biotechnologie


As a preferred supplier for Roche Basel we are looking for an individual as

Senior Quality Validation Analyst

(contract until 31.12.2022, with possible extension). The earliest start date is within 2 months. Remote/Homeoffice possible, max. 50% after onboarding.


  • Creating and/or reviewing risk assessments, validation plans and reports
  • Providing validation and Compliance advice and guidance to project managers, project team, and IT Validation Leads
  • Reviewing and approving change controls
  • Periodically reviewing computer systems, creating/revising, and action annual quality plans
  • Assisting in Regulatory Inspections and Corporate Quality Audits
  • Preparation of project-based documentation for computerized system
  • Responsible for reviewing documents and approving Validation Documents with a focus on LEAN CSV/CSA processes
  • Support IT and Quality while discussing CSV strategy
  • Providing support and guidance to the global network for Discrepancy and CAPA resolution

Erforderliches Profil

  • Min. Bachelor degree in Computer Science or any similar
  • Min. 5-7 years of experience in IT Quality/Validation for the GMP area
  • Sound intermediate-level knowledge of Computer System Validation Standards and Processes, including data integrity and data life cycle, computer system change control, testing, and the handling of deviations 
  • Intermediate knowledge of FDA 21 CFR Part 11, EU GMP Vol 4 Annex 11, GAMP 5.0
  • Proficiency in EDMS, ALM Software (HPALM), Service NOW, Google Suite
  • Fluency in English, German is a plus
  • Root cause analysis and problem-solving skills
  • Ability to take efficient and effective decisions within a reasonable timeline
  • De-escalation skills
  • Strong organizational and technical writing and verbal communication skills

Nice to Haves:

  • Previous Roche IT or Quality Validation experience
  • Advanced Analytics (ML/AI) experience
  • Agile experience (e.g. Scrum or SAFe 5.0)
  • ITIL Processes experience

Application process

Interested? You can find more information here: Infopackage. Please apply via the "Bewerben" button below and answer all questions, otherwise we will be unable to process your application.


  • Agentur GPP AG - GLOBAL RECRUITMENT - +41 44 266 50 25
  • Veröffentlicht am 18. Mai 2022
  • Berater-in Jie Zhu