We are looking for a **Validation Specialist** to join the Quality Validation team based in Piombino Dese (PD).
The function ensures the approval and validation of all production processes and supporting IT systems, as well as utilities, test methods, equipment and cleaning processes, producing a product that meets all applicable internal and regulatory requirements.
The function is part of a corporate team, with multi-site responsibility.
The figure will be involved in the following main activities:
- Develop, execute and review documents related to Validation activities (e.g.
validation plan, protocol, report, technical document, risk assessment), including management of deviations;




- Execute and/or coordinate assigned Validation activities related to Qualification and Validation area;
- Management of Change control related to production processes as assigned;
- Interfacing with suppliers/internal companies within the group to collect the information necessary for the preparation and/or review of protocols;
- Assist during FAT, SAT and IOQ with Engineering and Supplier;
- Participate at workshops/projects for continuous improvement and global standardization initiatives within organization;
- Support maintenance of document GMP archive including the responsibility for correct consultation, data collection, retrieval and returning of documents and archiving process.
**Guideline and Procedures**
- Receives and communicates best practices, knowledge and technical skills of the guidelines on quality, directive and procedures for the relevant processes in order to promote a Quality-oriented mentality and compliance processes;
**Quality Audit Management**
- Participates in the audit sessions as well as during the customers technical meeting in order to provide services and accurate response on assigned processes, working closely with the involved teams, able at solving the relevant findings,



ensuring sustainable and long-term efficacy and efficiency at both processes and systems level.
**Project Management**
- Participates actively and proactively in the assigned projects, providing the project team with delivered actions acting as enabler of synergy and efficiency across the involved processes.
- Interacts and communicates regularly and effectively with the team and functions involved aimed at fostering the knowledge sharing approach and circulation of information across the organization.
**Qualifications**
- Scientific Master's Degree
- ** +3** years' experience in Validation in a multinational company (preferably in a pharmaceutical and medical devices company);
- Knowledge of applicable regulatory, standards, global manufacturing practices;
- Knowledge of Technologies and Product and Production;
- Knowledge of Quality Management System;
- Knowledge of the main Quality tools as CAPA, Change Control Management, Deviations, OOS,



audits;
- ** Good English language proficiency**
LI-DNI
**About Us**
We are a dynamic organization with great customers and a culture where people are valued and empowered to deliver amazing results.
We are also growing and looking to hire talented and passionate individuals to join our team!