Beschreibung
Senior Quality Validation Analyst (m/f/d)
Reference: -en
Start: asap
Duration: 6 MM++
Main tasks:
- 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
Main qualifications
- Bachelor degree in Computer Science or any similar
- Strong 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
Main advantages:
- A very renowed company
- You will work in an internation environment
About us:
IT is and always has been our core business that laid the foundation for Hays' success. We are the biggest privately owned IT recruitment agency in Germany and offer the best jobs for every career level – whether you are interested in vacancies in agile SMEs or international DAX groups. Hays masters the entire IT job spectrum, from support to software architecture or digitalisation – thanks to our broad portfolio, we have something for everyone. In the last decades, we were able to support numerous IT experts with choosing the right path for a successful career, positioning ourselves as their lifelong partner. Our highly specialised consultants can cater to your every wish and expectation and will prepare you for interviews and contract negotiations. Give it a try and learn what the market has to offer – our services are free of charge, non-binding and discreet! We look forward to hearing from you.
My contact at Hays:
My contact person:
Roberta Mengheres
Referencenumber:
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