08 set - Parma
Biopharma Careers
About usChiesi 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.
Chiesi Research & DevelopmentOur R&D; team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D; project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada)
and Shanghai (China).
Who we are looking forThe Global R&D; QA, Senior Validation, Digital & Data Integrity Specialist ensures the maintenance in a state of control and validation of software systems involved in GXP process. Ensures Project Management for relevant projects.
You will be responsible for
- 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
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