Quality Assurance Associate

1 settimana fa

Rome, Italia Consulting Consulenza Coaching A tempo pieno

We are seeking a dedicated and detail-orientedQuality 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 agreementsManage and overseeGMP deviations , including investigation and documentationFollow-up on activities related to supplier performanceSupport change control processes to ensure effective management of supplier changes.Supported the development and implementation of mitigation and remediation plans forAnnex 1compliance 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 overseeGMP deviations , including investigation and documentationCoordinate and reviewroot cause analysisand risk assessmentsEnsure compliance withGMP requirementsand support audits and inspectionsStrong organizational skills and attention to detail.Experienced in aseptic practices andAnnex 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.Who are we? Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 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.#J-18808-Ljbffr

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