Beschreibung
Senior Quality Validation Analyst - GMP / CSV / ALM / EnglishRole: For our client in the Pharma industry based Basel region 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.
Background: In 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.
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:
- Bachelor degree in Computer Science or any similar
- 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
Reference no: 921533SKN
Role: Senior Quality Validation Analyst
Industry: Pharmaceutical industry
Workload: 100%
Location: Basel, Switzerland
Start date: July 2022
Duration: 12+ months (Extension possible)
About us: ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.