Validation Specialist

We are looking for a Validation Specialist – Quality to join our HQ team in Piombino Dese (Padova) . The chosen candidate will be responsible to execute the qualification and validation processes assigned, maintains UpToDate and improves the quality system tools, guidelines, and other procedures aimed at achieving reliability and compliance, in alignment with the applicable standards, such as ISO, CE, cGMP and other local requirements.

Key Responsibilities

• 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.
• 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.
• Provides technical support to other functions involved in order to ensure the full application of the relevant QMS for what concerns validations process.
• 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.
• 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.
• Participates in the assigned projects, providing the project team with delivered actions acting as enabler of synergy and efficiency across the involved processes.

Qualifications

• 2 years proven experience gained in Validation area within quality pharmaceutical companies
• Technical Master Degree
• Knowledge of applicable regulatory, standards global manufacturing practices, such as local regulatory, cGMP requirements and ISO standards
• Knowledge of Quality Management System: process, features techniques
• Knowledge of the internal audit: process, features techniques
• Project Management and Risk Management: methodologies, techniques, tools and applications
• Analysis and Reporting: methodologies, techniques, tools and applications

About Us

We 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!