Quality Validation Manager (9321) Ne

Quality Validation Manager (9321)
Ne
Liguria, Ne

We are looking for a **Quality Validation Manager** to be insert in our Corporate Quality Department in the headquarter in **Piombino Dese (PD)

Stevanato Group is an Italian but multinational manifacturing company.

We develop and **produce drug containment solutions in glass and plastics**.

The main production process is the the processing of the glass tube by **forming** and the subsequent **cleaning** and **sterilization** of the container using **highly automated machinery.

The function of Validation team is to ensure 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 **Quality Validation Manager** is responsible for the qualification and validation processes and for the definition, implementation and improvement of quality and system standards, guidelines and procedures for the areas assigned at global level, ensuring reliability and compliance, according with the applicable standards such as ISO, CE, cGMP as well as other local requirements.

**KEY ACCOUNTABILITIES

- Defines the qualification and validation plan, aimed at ensuring the expected level of services and the validation master plan updating and accuracy, for the relevant lines/ areas assigned at global level.

- Ensures the promptly executions of activities required for achieving the validation targets according with the level of services and timing defined into the approved plan, guaranteeing the compliance with applicable standards, working closely with the other Quality functions.

- Oversees timely and accurate validation documents and third parts reports, troubleshoots validation issues, working alongside with the functions involved and according to the priorities assigned by the manager above.

- Collaborates with the Commercial Team to carry out new projects ensuring technical assistance and validation, as well as with the R&D Team in order to define appropriate processes to guarantee the quality and reliability of the products and processes.

- Defines best in class validation practices, ensuring inclusion within the relevant quality management system, cascades accurate and up-to-date information related to regulations, standards and customer requirements to the team and to the other functions involved into the processes.

- Manages the inspections audit for what concern validation aspects and implements corrective and preventive actions working closely with the other functions involved.

- Defines and monitors the KPIs related to validation in order to meet internal and external needs, highlighting timely deviations and critical issues and proposes to the Leader above actionable initiatives in order to address them.

- Manages, coaches and develops assigned staff, ensuring the effective talent management of assigned personnel in term of training and career development.

**Qualifications

- Scientific Master's Degree

- ** +7 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 the main Quality tools as CAPA, Change Control Management, Deviations, OOS, audits;

- ** Good English language proficiency

**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!