Quality Validation Specialist: Analytical Methods & GMP

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

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.