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Quality Assurance Specialist

2 mesi fa

Villa Latina, Lazio, Italia Stevanato Group A tempo pieno

Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our Quality Validation team at Stevanato Group. As a key member of our team, you will be responsible for ensuring the approval and validation of all production processes and supporting IT systems, as well as utilities, test methods, equipment, and cleaning processes.

Key Responsibilities

  • Execute qualification and validation activities to achieve validation targets in accordance with approved plans, ensuring compliance with applicable standards.
  • Support the leader in defining qualification and validation activities to ensure compliance with quality management systems and regulatory requirements.
  • Provide timely and accurate validation documents, monitoring third-party reports for review by the leader.
  • Collaborate with the Commercial Team to carry out new projects, ensuring technical assistance and validation, as well as with the R&D Team to define appropriate processes for quality and reliability of products.

Guidelines and Procedures

  • Contribute to cascading accurate and up-to-date information related to regulations, customer requirements, and other applicable standards to the team and other functions involved in processes.
  • Support the definition of validation practices, ensuring inclusion within the relevant quality management system.
  • Provide technical support to other functions involved to ensure full application of the relevant quality management system for validation processes.

Quality Audit Management

  • Participate in audit sessions and customer technical meetings to provide accurate and timely technical services and support for relevant topics, execute corrective and preventive actions assigned, working closely with involved teams.

Reporting and Monitoring

  • Elaborate reports to monitor KPIs related to validation and meet internal and external needs, highlighting timely deviations and critical issues, and propose actionable initiatives to achieve effective resolution.

Requirements

  • Scientific Master's Degree
  • +2 years' experience in Validation in a multinational company (preferably in a pharmaceutical and medical devices company)
  • Knowledge of internal audit: process, features, techniques
  • Knowledge of applicable regulatory, standards, global manufacturing practices
  • Legal and standard requirements linked to relevant applicable standards
  • IT Tool
  • Good English language proficiency

Availability to travel within the national territory is required.