Job Description
We are looking for Quality Management System Specialist to be insert in our quality department, in Piombino Dese (PD).
Stevanato Group is an Italian but multinational manufacturing 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 Ideal candidate carries out all the activities in order to guarantee the management system compliance with applicable standards, guidelines and regulations; maintains the relevant quality management system, processes, procedures, directives and tools, monitoring that continuously meet requirements.
KEY ACCOUNTABILITIES
1. Contributes to implement and maintain UpToDate the relevant management system, ensuring the compliance with the applicable regulations, directives, standards and regulatory requirements.
2. 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.
3. 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.
4. Participates in the procedure standardisation, alongside the different international plants and functions for fostering best quality practice and promoting one SG quality approach.
5. 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.
6. 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.
7. 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
Qualifications
8. Master's degree in scientific university
9. 3/4 years of experience in a similar role
10. Full professional proficiency in Italian and English
11. Knowledge of applicable regulatory requirements, standards such as local regulatory requirements, cGMP requirements, FDA regulations and ISO standards
12. Knowledge of CAPA, Change, Deviations: process, features techniques
Adherence to Stevanato Group’s Values: Trust and respect everyone; Be accountable; Be ethical, always; Listen and communicate with transparency and honesty; Deliver results