Specialista Di Validazione

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b7vvv

Company Overview Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We're focused on building and nurturing a top talent community where all our team members can achieve their full potential.
Job Description We are seeking a dedicated and detail-oriented Quality Validation Analyst to join our team. The successful candidate will play a crucial role in supporting quality and validation activities within a GMP-regulated pharmaceutical environment, ensuring compliance with regulatory requirements and internal quality standards.
Key Responsibilities Execute and support analytical method validation activities in accordance with GMP requirements and ICH Q2(R2) guidelines.



Perform validation studies, including accuracy, precision, specificity, linearity, range, and robustness, ensuring reliable analytical data.
Conduct analytical testing required to support method validation and verification activities.
Support Analytical Method Transfer activities between laboratories, ensuring successful execution of transfer protocols and evaluation of results.
Prepare, review, and maintain validation documentation in compliance with GMP requirements and Data Integrity (ALCOA+) principles.
Operate, verify the performance of, and support the maintenance of analytical instruments, including HPLC, UPLC, GC, UV‐Vis, Dissolution, and Karl Fischer systems, ensuring instrument suitability and compliance.
Collaborate closely with Quality Assurance (QA), Quality Control (QC), Manufacturing, Regulatory Affairs, and Supply Chain teams to ensure effective investigation, escalation, and

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b7vvv