Quality Validation Specialist

6 mesi fa

Province of Latina, Italia Stevanato Group A tempo pieno

Job Description


We are looking for a Validation Specialist to join the Quality Validation team based in Cisterna di Latina (LT).

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 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 figure will be involved in the following main activities:

VALIDATION MANAGEMENT
• Executes the qualification and validation activities in order to achieve the validation targets according with the level of services and timing defined into the approved plan, guaranteeing the compliance with applicable standards.
• Supports the leader above in the definition of the qualification and validation activities, aimed at ensuring the compliance of the quality management system with applicable standards and requirements.
• Provides timely and accurate all the validation documents, monitoring also thirds parts reports to be reviewed by the leader above for the final submission.
• Participates alongside the Commercial Team to carry out new projects ensuring technical assistance and validation, as well as with R&D Team to define appropriate processes to guarantee the quality and reliability of the products.


GUIDELINES AND PROCEDURES
• Contributes to cascade accurate and up-to-date information related to regulations, customer requirements and other applicable standards to the team and to the other functions involved into the processes.
• Support the validation practices definition, ensuring inclusion within the relevant quality management system.
• Provides technical support to other functions involved in order to ensure the full application of the relevant quality management system for what concerns validations process.


QUALITY AUDIT MANAGEMENT
• Participates in the audit sessions as well as during the customers technical meetings in order to provide accurate and timely technical services and support for the relevant topic, executes corrective and preventive actions assigned
working closely with the involved teams.


REPORTING AND MONITORING
• Elaborates appropriate reports in order to monitor KPIs related to validation and meet internal and external needs, highlighting timely deviations and critical issues and propose to the leader above actionable initiatives in order to achieve appropriately and effectively resolution.

Qualifications


Scientific Master’s Degree +2 years’ experience in Validation in a multinational company (preferably in a pharmaceutical and medical devices company)
 Knowledge of the 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.

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