Quality Compliance Specialist (8660) Ne

Quality Compliance Specialist (8660)
Ne
Liguria, Ne

We are looking for _Quality compliance specialist_ to be insert in our quality compliance department in** Piombino Dese** (PD) directly reporting to** **Quality Compliance Manager.

**Management system compliance execution

- Contributes to implement and maintain UpToDate the relevant management system, ensuring the compliance with the applicable regulations, directives, standards and regulatory requirements.

- Executes continuous analysis in order to monitor national and international standards, regulatory requirements and changes, working with the other functions involved and according to the leader above.

- Assess the efficiency, proposing to the leader above effective improvements and keeps the management system updated accordingly relevant changes, working alongside with the other functions involved such as internal auditing Team.

- Participates in the procedure standardization, alongside the different international plants and functions for fostering best quality practice and promoting one SG quality approach.

**Audit and review management

- Provides support to the leader above in the preparation of audit and inspection sessions in order to provide the response related to the compliance of the relevant quality management system.

- Identifies compliance issues that require investigation, evaluating risks and implements, according to the leader above, corrective and preventive actions with the aim of reducing non-conformity and observation.

- Provides technical support to the functions involved in managing the process change control and the corrective and preventive actions related to the compliance topics.

**Training management

- Participates in the training processes for the relevant topics, ensuring the compliance with applicable standards, procedures, working with the HR Team and others relevant functions.

**Guidelines and procedures

- Keeps up-to-date relevant operating procedures and instructions in order to guarantee standardization and harmonization of the service provided in alignment with the relevant system standards and regulations.

- Assist the leader above with the relevant documents and declaration (such as Position Papers) explaining positions in relation to specific topics or regulations and consolidates the annual management review.

- Promptly transfers and provides the involved team with complete and accurate data, information, reports and documentation in order to ensure the effectively and efficiently alignment.

**Technical quality agreement management

- Contributes effectively in the standard TQA consolidation, keeping the content up to date and reviews it when occurs respect quality system in place and applicable standards.

**Qualifications

- Master's degree in scientific university

- 3/4 years of experience in a similar role

- Full professional proficiency in Italian and English

- Knowledge of applicable regulatory requirements, standards such as local regulatory requirements, cGMP requirements, FDA regulations and ISO standards

- Legal and standard requirements linked to the relevant standard applicable

- Knowledge of Technologies and Product and Production: process, features techniques

- Knowledge of Compliance Management System: process, features techniques

- Knowledge of CAPA, Change, Deviations: process, features techniques

- Knowledge of the internal audit: process, features techniques

- Analytical Approach, Problem Solving, Risk Based Thinking Approach, Economic understanding, Result mindset

LI-DNI

- Adherence to Stevanato Group's Values_: Trust and respect everyone; Be accountable; Be ethical, always; Listen and communicate with transparency and honesty; Deliver results.

**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!