Quality Validation Specialist LATINA

Quality Validation Specialist
Latina
Lazio, LATINA

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 processing of the glass tube by forming and the subsequent cleaning and sterilization of the container using highly automated machinery. The function of the 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. Main ActivitiesVALIDATION MANAGEMENTExecutes 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 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 third-party 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 PROCEDURESContributes 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 in the processes. Supports 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 MANAGEMENTParticipates 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, executing corrective and preventive actions assigned working closely with the involved teams. REPORTING AND MONITORINGElaborates appropriate reports in order to monitor KPIs related to validation and meet internal and external needs, highlighting timely deviations and critical issues and proposing to the leader above actionable initiatives in order to achieve appropriately and effectively resolution. QualificationsScientific 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 techniquesKnowledge of applicable regulatory, standards, global manufacturing practices;Legal and standard requirements linked to the relevant applicable standardIT ToolGood English language proficiencyAvailability to travel within the national territory is required.

About UsWe 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!

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