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Quality Assurance Specialist
2 mesi fa
Job Title: Quality Validation Specialist
Job Summary:
We are seeking a highly skilled Quality Validation Specialist to join our Quality Validation team at Stevanato Group. As a Quality Validation Specialist, 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, producing a product that meets all applicable internal and regulatory requirements.
Key Responsibilities:
Validation Management:
- Execute qualification and validation activities to achieve validation targets in accordance with the level of services and timing defined in the approved plan, ensuring compliance with applicable standards.
- Support the leader in defining qualification and validation activities to ensure compliance of the quality management system with applicable standards and requirements.
- Provide timely and accurate validation documents, monitoring third-party reports for review by the leader for final submission.
- Participate 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 to guarantee the 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 the processes.
- Support the validation practices definition, ensuring inclusion within the relevant quality management system.
- Provide technical support to other functions involved to ensure the full application of the relevant quality management system for what concerns 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 appropriate reports to monitor KPIs related to validation and meet internal and external needs, highlighting timely deviations and critical issues, and propose actionable initiatives to the leader 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 the relevant applicable standard
- IT Tool
- Good English language proficiency
Availability to travel within the national territory is required.
