Beschreibung
Senior Quality Validation Analyst (IT) m.w.xIn this position, you will work in the global quality unit. The team works closely and collaboratively with IT testing and Business collaborates in delivering and maintaining Validated Computerized Systems.
The perfect candidate:
We are looking for a senior candidate who has his focus of experience in Quality and Validation with a background of manufacturing and knows the mentioned software's in the must have criteria's. The experience should come from a pharmaceutical, biotech or at least GMP environment.
Tasks & Responsibilities:
- 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
Must Haves:
- 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:
- Advanced Analytics (ML/AI) experience
- Agile experience (e.g. Scrum or SAFe 5.0)
- ITIL Processes experience
General Information:
- Start date: ASAP
- latest Start Date: 01.07.2022
- End date: 31.12.2022
- Extension: possible
- Workplace: Basel
- Workload: 100%
- Team: 6 people
- Remote/Home Office: yes, max. 50% after onboarding
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.