Einzelheiten
- Region Basel
- Art des Vertrags Temporär - Vollzeit
- Tätigkeitssektor Chemie / Pharma / Biotechnologie
Einführung
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.
Aufgabenbeschreibung
- 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.
Informationen
- Agentur GPP AG - GLOBAL RECRUITMENT - +41 44 266 50 25
- Veröffentlicht am 18. Mai 2022
- Berater-in Jie Zhu
