Specialista Di Validazione

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 resolution of quality events. Contribute to continuous improvement initiatives aimed at enhancing quality systems, compliance, and operational efficiency. Qualifications

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. Benefits

Salary for experienced consultant from 26,000 to 50,000 K. International and multicultural work environment within a fast-growing consulting company. Clear career path with personalized growth opportunities (both vertical and horizontal). Continuous training and development programs through our internal Academy. Opportunity to contribute to innovative projects with leading international clients in the Life Sciences sector. 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.

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