Validation Specialist

Stevanato-Group; Piombino Dese; In loco; EUR 50.000 - 75.000; Tempo pieno

Descrizione del lavoro

Stevanato Group is seeking a Quality Validation professional to ensure the approval and validation of production processes, meeting quality and regulatory requirements. You will contribute to validation of analytical methods, support method transfer, and collaborate with Commercial, R&D, and manufacturing teams to guarantee product quality and reliability.

The role emphasizes development, validation, and timely documentation, with a focus on GMP guidelines and international standards.

Competenze

• Must support qualification and validation activities to meet quality and regulatory requirements.
• Experience in analytical method validation protocols and reports per GMP.
• Ability to perform data analysis and statistical evaluation to demonstrate method suitability.
• Ability to work with R&D, Commercial teams and laboratories to ensure product quality.

Mansioni

• Execute qualification and validation activities to meet targets per approved plan.
• Support definition of qualification and validation activities ensuring QMS compliance.
• Provide timely validation documents and review third-party reports for final submission.
• Collaborate with Commercial and R&D teams to define processes for quality and reliability.
• Support development, transfer and validation of analytical test methods for product/process verification.
• Author and review analytical method validation protocols and reports per GMP and guidelines.
• Define validation strategies and acceptance criteria for analytical methods (accuracy, precision, specificity, linearity, range, robustness, LOD/LOQ).
• Support analytical method transfer between labs and manufacturing sites.
• Perform data analysis to demonstrate method suitability and maintain validated state.
• Contribute to updating regulations, requirements and standards within the team and processes.
• Support validation practices definition within the quality management system.
• Provide technical support to ensure the full application of the QMS for validations.
• Contribute to defining and improving analytical method validation procedures per GMP and guidance (ICH Q2(R2), ICH Q14).
• Participate in audit sessions and customer meetings to provide technical services and support.
• Elaborate reports to monitor KPIs related to validation and propose actionable initiatives.

Conoscenze

Quality Validation

GMP awareness

Analytical method validation

Cross-functional collaboration

Descrizione del lavoro

At Stevanato Group, what we do matters. Every solution we develop contributes to delivering life‑changing treatments to patients around the world.

In this role, you will play a key part in the Quality Validation team, ensuring the approval and validation of all production processes and supporting functions producing a product that meets quality and regulatory requirements.

You will contribute to our ambition to solve what matters, together, combining technical excellence, collaboration, and a strong sense of ownership.

What You’ll Do

VALIDATION MANAGEMENT

• Execute the qualification and validation activities to achieve the validation targets according to the level of services and timing defined in the approved plan, guaranteeing compliance with applicable standards.
• Support the leader above in the definition of the qualification and validation activities, aimed at ensuring compliance with the quality management system with applicable standards and requirements.
• Provide timely and accurate all the validation documents, monitoring also third parts reports to be reviewed by theleader above for the final submission.
• Participate 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.
• Support the development, optimization, transfer and validation of analytical test methods used for product, process verification activities.
• Author and review analytical method validation protocols and reports in accordance with applicable GMP requirements and international guidelines.
• Define validation strategies and acceptance criteria for analytical methods, including assessment of accuracy, precision, specificity, linearity, range, robustness, detection limits and quantification limits.
• Support analytical method transfer activities between laboratories and manufacturing sites.
• Perform data analysis and statistical evaluation to demonstrate method suitability and maintain the validated state throughout the method lifecycle.

GUIDELINES AND PROCEDURES

• Contribute to cascade accurate and up-to-date information related to regulations, customer requirements, and otherapplicable 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.
• Provide technical support to other functions involved to ensure the full application of the relevant qualitymanagement system for what concerns validations process.
• Contribute to the definition and continuous improvement of analytical method validation procedures in compliance with GMP requirements and international guidance (e.g. ICH Q2(R2), ICH Q14 and applicable pharmacopoeia standards).

QUALITY AUDIT MANAGEMENT

• Participate in the audit sessions as well as during the customers technical meetings 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

• Elaborate appropriate reports 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 to achieve appropriate and effective resolution.

In this role, you are encouraged to:

• Take ownership of outcomes, not just tasks
• Bring ideas forward and turn them into solutions
• Collaborate openly and contribute to shared success

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!