Quality Assurance Associate

12 ore fa


Rome, Italia MANTU GROUP SA A tempo pieno

Who are we? 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. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like: Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you The objective? Learn about you, understand your motivations, and make sure we have the right job for you Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. 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 Case study: 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. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience. We look forward to meeting you Job description We are seeking a dedicated and detail‑oriented Quality Assurance Specialist (remote). The successful candidate will play a crucial role in supporting the Supplier Quality organization by managing supplier‑related activities and ensuring compliance with quality standards. Your missionsMaintain and update records related to external suppliers, including information on materials, qualifications, and monitoring activities. Assist in supplier assessments and manage supplier documentation, including:Specifications agreements Manage and oversee GMP deviations, including investigation and documentation Follow‑up on activities related to supplier performance Support change control processes to ensure effective management of supplier changes.Supported the development and implementation of mitigation and remediation plans for Annex 1 compliance gaps identified during EQSM aseptic on‑site assessments at key parenteral CMOs. Collaborated with cross‑functional teams and CMOs to address findings from audits and proactive compliance assessments, ensuring timely and effective remediation aligned with current Annex 1 requirements. Ensure alignment of delays and potential capex with PES, EQ, MSAT and MQSA. Collaborate on projects as part of a team.Your profileScientific degree in a relevant field (Pharmaceutical Sciences, Biology, Chemistry, or related area). Proficiency in English (mandatory). Manage and oversee GMP deviations, including investigation and documentation Coordinate and review root cause analysis and risk assessments Ensure compliance with GMP requirements and support audits and inspections Strong organizational skills and attention to detail. Experienced in aseptic practices and Annex 1. Excellent written and verbal communication skills.What we offerAn 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.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



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