Computer System Validation Specialist for Pharma

**_Milano_** **_, _** **_Italy_** **_ _** **We are looking to expand our Advisory and Consultancy division with several CSV (Computer System Validation) specialists with expertise in the Life Science industry. **Minimum Seniority**: **Technical**: **Commercial**: **Quality Assurance**: **Administration**: **Responsibilities**: - ** Support our Customers validation projects by**: - Defining and writing Validation Plans, Validation Reports, Test plans, Acceptance tests, User Requirements, etc. - Writing and reviewing Standard Operating Procedures and Work Instructions. - Drafting of Design and Functional Specification documents in cooperation with our System or Process Engineers and managing formal revision and approval processes. - Writing and executing IQ/OQ/PQ test protocols for computer systems, processes, equipment and utilities. - Performing Technical Impact Assessments. - Writing and reviewing Calibration and Maintenance Plans. - IT/OT Infrastructure Qualification plan, tests and procedures writing and review. - ** Provide cross-functional cooperation with our Engineering Teams**: - Learn foundations of IT, OT and process engineering. - Facilitate interdepartmental Quality, Engineering, IT communications. - Support internal quality processes. - Support documental standardisation. **Must Have**: - Very good knowledge of pharma standards and regulations (ISPE GAMP and GxP, EUDRALEX, FDA CFR 21, etc.). - Minimum 2 years previous consulting experience in Computer Systems Validation for the pharmaceutical sector. - Language skills: Italian and English CEFR C1 level or higher (read, written and spoken - the interview will be held in both languages). - Utmost professionalism and seriousness towards customers and colleagues. - Care towards the relationship with and to the management of the Customer. - European citizen or possession of a valid residence and work permit in the European Community commencing employment start date. - Complete autonomy in the professional use of the following software / IT tools: - Google Documents (drafting of documents and letters, minutes, formatting and organisation of text, etc.) - Google Sheets (data entry, use of the basic formulas, data extraction and use of pivot tables) - Scientific/tech high school diploma or university degree. - Driving licence B or equivalent recognized in the EU and valid. - Previous work experience in multinational companies, or on their behalf. **Position details**: - **Primary job location**: Milan, Italy (3 vacancies). - Travel: tbd - ** Type**: Full time - ** Business unit: Advisory and Consultancy**: - ** Level and salary**: employment contract of the Confcommercio Tertiary National Collective Labour Agreement with a classification between L3 and L1 depending on the actual experience achieved + bonus, training and welfare plan (backgrounds and expertise will be assessed). **What We Offer**: Ample opportunity for **career development**. **Full-time employment contract** of the Confcommercio Tertiary National Collective Labour Agreement with a classification between L3 and L1 depending on the actual experience achieved. **Objective plan** and** bonuses** starting from the fourth month. Standard MAASI welfare: - access to the corporate welfare plan, - meal vouchers, - reimbursement of travel and any expenses incurred, - overtime always paid according to legislation, - training and development plan **Rewarding**: A salary pack that matches your responsibilities, a growth plan and attractive bonuses on results base. **Trainings**: Internal and external trainings specifically selected on your aptitudes and talent. **Welfare plan**: A set of benefits, services and affiliations on top to the profession's health insurance. **we're Humans**: We're a Company of human beings, before anything else. You'll never be "just a number" here.