Wrocław, POL
2 days ago
Validation Specialist (Quality Management)
**The position** Joining our company, you will gather an overview of the GBS Enabling Services Organization with a particular focus on the tasks and responsibilities of Validation Management. You are working in a globally operating team that designs, builds and continuously improves Boehringer Ingelheim’s global Processes, using agile principles, methods and tools daily. You will be equipped to actively contribute within a cross-functional team and serve as a Validation Specialist throughout the lifecycle of computer systems that support quality processes. This includes managing change requests, reviewing impact analyses and approving documentation, ensuring the computer systems remain in a validated state. **Tasks & responsibilities** • Act as a Validation Management Specialist, supporting daily validation activities of quality-related computer systems, in line with global procedures. • Ensure Computer Systems remain compliant and in a validated state by overseeing the System Lifecycle documentation and testing of computer systems. • Leverage your expertise in Computer System Validation to ensure changes are managed in compliance with validation requirements, and in close collaboration with experts. • Participate in Agile-driven projects, applying relevant methods and tools effectively. • Work within project frameworks that are measured by KPIs and SLAs, continuously identifying and implementing improvement opportunities. **About our future employee** You should speak English fluently (min. C1 level) and have around 2-4 years of experience in validation/QA area. **Additionally, we are looking for:** • Bachelor’s Degree; preferably in engineering, sciences, pharmaceuticals or biotechnology or equivalent and longstanding professional experience in regulations and processes. • Hands-on experience in electronic Quality Management Systems (TrackWise, Veeva) and/or related pharma experience (Quality Management). • Profound knowledge and understanding of Computer Systems Validation regulation (CSV), including GAMP5, 21CFR Part 11, FDA CSA framework,EU Annex 11, and Data Integrity. • Good Knowledge of GxP (Good Practices) regulations within the Pharmaceutical Industry. • Experience with agile methods (e.g., SCRUM, Kanban) and tools (e.g., JIRA, Confluence) would be an advantage. • Good analytical capabilities and problem-solving competence including a proper understanding of prioritization. • Dedicated team player with good communication skills, and a structured way of working. All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
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