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 the generation of 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 resolution of quality events. Contribute to continuous improvement initiatives aimed at enhancing quality systems, compliance, and operational efficiency. Your profile Scientific degree in a relevant field (Pharmaceutical Sciences, Biology, Chemistry, or related area). Proficiency in English (mandatory). Strong organizational skills and attention to detail. Ability to work collaboratively in a team environment. Excellent written and verbal communication skills. What we offer Salary for experienced consultant from 26000 to 50000 K. An international and multicultural work environment within a fast‑growing consulting company. A clear career path with personalized growth opportunities (both vertical and horizontal). Continuous training and development programs through our internal Academy. The opportunity to contribute to innovative projects with leading international clients in the Life Sciences sector. Equal Opportunity Statement
At Amaris Consulting, we believe that diversity is a strength and we are proud to be an equal opportunities employer. We welcome applications from all backgrounds and are committed to fostering an inclusive environment where every voice is heard and valued. #J-18808-Ljbffr

📌 Specialista di validazione (Roma)
🏢 Amaris Consulting
📍 Roma