COMPUTER SYSTEM VALIDATION & DATA INTEGRITY CONSULTANT – GMP

Orienta Orienta Spa, Benefit subsidiary of Verona, is seeking a/one: COMPUTER SYSTEM VALIDATION & DATA INTEGRITY CONSULTANT – GMP. The resource will be inserted into projects at pharmaceutical companies and API producers, with a focus on the GMP world. It will deal with software validation and documentary management activities in the fields of production systems and QC laboratories. In particular: - Execution of GMP assessments on computerized systems and digital processes - Preparation of validation documentation: URS, Risk Assessment, Validation Plan, IQ/OQ/PQ, SOP - Monitoring compliance of systems with regulatory requirements (EU GMP Annex 11, FDA 21 CFR Part 11) - Analysis and implementation of Data Integrity principles (ALCOA+) - Support for managing deviations, change control, and CAPA related to computerized systems - Periodic verification of systems and drafting reports on status - Collaboration with QA, IT, Production, and QC to ensure full GMP compliance. Requirements: - Bachelor's degree in scientific disciplines (CTF, Biotechnology, Chemistry, Engineering or equivalents) - Previous experience in CSV contexts GMP - Knowledge of European pharmaceutical regulations and FDA - Analytical skills, precision, and documentary management capabilities - Excellent communication skills and consulting attitude Soft Skills - Problem-solving and customer-oriented - Ability to work in multidisciplinary teams - Operational autonomy - Confidentiality and attention to detail. Offer: - Direct insertion into the company - Collective Labor Agreement applied: Chemical Industry * 13 months - Working hours: Full-time 40 hours from Monday to Friday The working schedule provides for 70% smart working, while the remaining 30% will be dedicated to activities on site and at assigned clients for project monitoring. For candidates residing in Verona or nearby areas, a presence in office equal to 50% is required. Indicative workplaces: VERONA - PARMA- PADOVA - MILANO Sector: Information Technology Role: IT/Technology Manages other people: No Type of occupation: Open-ended contract