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Senior Quality Validation Analyst

Senior Quality Validation Analyst

Pharmaceutical / Biotechnology / Chemical
  • Temporary full time
  • Reference : INT-029652
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Details

  • Region Basel
  • Type of contract Temporary full time
  • Sector of activity Pharmaceutical / Biotechnology / Chemical

Introduction

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.

Description of the mission

  • 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


Required profile

  • 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.

Information

  • Reference INT-029652
  • Published on 18 mai 2022
  • ConsultantMarijke van Engelenburg