06 ago
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Amaris Consulting
|
Roma
06 ago
Amaris Consulting
Roma
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. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success. At Amaris, we strive to provide our candidates with the best possible recruitment experience.
Brief Call : Our process typically begins with a brief virtual/phone conversation to get to know you! We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc. As you know, every person is different and so is every role in a company.
However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience. 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).
What we offer Salary for experienced consultant from 26000 to 50000K An international and multicultural work environment within a fast-growing consulting company. 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.
At Amaris
Consulting, we believe that diversity is a strength and we are proud to be an equal opportunities employer.
📌 Specialist-Spa (Roma)
🏢 Amaris Consulting
📍 Roma