FIS is Italy’s leading company in the development and production of active pharmaceutical ingredients and intermediates for the global pharmaceutical industry. With three manufacturing sites and more than 2,300 professionals, we have been committed for nearly 70 years to research, quality, and sustainability. Our products help improve the lives of millions of people worldwide—a responsibility we embrace with pride and passion. Join our team and become part of a company that grows through the dedication of the people who shape it every day.
La preghiamo di leggere attentamente la seguente descrizione del lavoro per assicurarsi di essere la persona giusta per questo ruolo prima di candidarsi.
Job purpose The
Quality Assurance Business Analyst
serves as the primary bridge between Quality Assurance (QA), Regulatory Affairs (RA), and the IT department. This role is responsible for streamlining, implementing, and managing IT systems that support compliance processes. The candidate will ensure that digital solutions align with business objectives and meet international regulatory requirements, managing the full lifecycle of IT projects within their area of expertise.
Main responsibilities: Process Analysis:
Analyze existing workflows within QA and Regulatory departments to identify opportunities for digitalization and operational efficiency. IT Project Management:
Support the implementation of specialized software (e.g., eQMS, RIM - Regulatory Information Management, Document Management Systems), acting as a IT Project Manager or primary liaison with external vendors. Requirements Gathering:
Translate business needs into detailed technical specifications, specifically creating and maintaining User Requirements Specifications (URS). Compliance & Validation:
Collaborate on Computer System Validation (CSV) activities in accordance with GAMP5 standards and industry regulations (FDA 21 CFR Part 11, EU Annex 11). Change Management:
Manage system Change Controls, assessing the impact of updates or modifications on quality and regulatory compliance. Training:
Organize and deliver training sessions for end-users to ensure proficient use of new digital tools.
Education & Experience: Bachelor in Engineering, Computer Science, CTF, Biotechnology, or a related field. At least 7 years of experience in similar roles, preferably within highly regulated industries (Pharma, Medical Devices, Life Sciences). Deep understanding of ISO 9001/13485, GxP, and software validation standards (GAMP5). Hands-on experience with Quality Management Systems (eQMS), Document Management Systems (DMS), or ERPs. Proficiency in Agile or Waterfall Project Management methodologies. Fluency in English (written and spoken) is mandatory.
Soft & Other Skills: Ability to break down complex problems into logical, scalable IT solutions. Capable of communicating effectively with both technical IT profiles and business stakeholders. Precision-driven with the ability to meet deadlines in high-stakes regulatory environments. Good negotiation skills to balance priorities across different users. xpavfwm
Office location: FIS Head Quarters is located in Montecchio Maggiore (Vicenza).