Global R&D; QA, Senior Validation, Digital & Data Integrity Specialist Chiesi • Parma, Emilia-Romagna, IT
About us
Chiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here. At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Vantaggi Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values,
each bringing unique perspectives that help us to continuously challenge the status quo for the better.
Who we are looking for
- Ensures Project Management for relevant projects.
- Coordination and supervision of the validation of computerized systems, particularly considering the impact of new digital technologies in the GxP environment (Validation Manager for Computerized Systems).
- Drafting validation procedures, validation plans (VPP), related summaries (VSR), and periodic validation reviews (PVR) in the software domain.
- Reviewing and approving, in the software domain: URS, functional specifications, qualification reports, and software procedures.
- Managing changes, deviations, and CAPAs related to software systems.
- Participating as a Technical Expert, with regard to validation aspects, in internal and external audits, including audits of software suppliers and especially clinical service providers, and suppor
📌 Global R&D Qa, Senior Validation, Digital (Parma)
🏢 Chiesi
📍 Parma