Quality Assurance Specialist

Quality Assurance Specialist (Senior) page is loaded## Quality Assurance Specialist (Senior)locations:
Singaporetime type:
Tempo integralposted on:
Publicado hojetime left to apply:
Data de término: 3 de outubro de 2025 (10 dias restantes para se candidatar)job requisition id:
Na Roche, você pode-se apresentar como você mesmo, abraçado pelas qualidades únicas que traz. Nossa cultura incentiva a expressão pessoal, o diálogo aberto e as conexões genuínas, onde você é valorizado e respeitado por quem você é, e permitindo que você prospere tanto pessoal como profissionalmente. É assim que pretendemos prevenir, deter e curar doenças e garantir que todos tenham acesso aos cuidados de saúde hoje e nas gerações futuras. Junte-se à Roche, onde cada voz é importante.### A posição****Quality Assurance Specialist****A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.That’s what makes us Roche.As a Quality Assurance Specialist, you're responsible for ensuring that all investigational and commercial medicinal products are manufactured in strict accordance with global Roche, Pharmaceutical Quality System (PQS), and local site standards. A key part of this is escalating quality issues based on criteria in current governing documents. Additionally, you will support or perform routine "Make, Assess, Release" operations to meet production targets and timelines. You'll also participate in designing and implementing both departmental and cross-functional initiatives, and may take on other responsibilities as required by Quality Management to meet overall business needs.**The Opportunity*** Ensuring Quality and Compliance: Review batch records, reports, logbooks, and other cGMP documents to ensure product quality and compliance with Roche requirements.* GMP Area Oversight: Conduct routine floorwalk, provide QA oversight for the release of GMP areas, utilities, and equipment.* Event Management: Assess the needs for event initiation and review justifications for resuming GMP processing.* Monitoring and Reporting: Review and approve environmental and utility trend reports.* Quality Assurance Audits: Perform audits for controlled documents and change controls.* Regulatory Support: Actively support regulatory inspections and partner audits as an MQA subject matter expert.* Training and Development: Serve as a trainer for MQA activities, preparing materials and conducting sessions as needed.* Team Collaboration: Foster a positive team environment and represent MQA in cross-functional meetings.****Who you are***** Education & Experience: A degree in Life Sciences or Engineering, with at least five years of relevant experience in a biotech or pharmaceutical setting.* Industry Knowledge: Strong grasp of quality systems, cGMP, and GDP principles and standards.* Decision-Making Skills: Ability to make sound, timely decisions on quality-related matters.* Organizational & Analytical Skills: Proven organizational and planning skills, with a meticulous and analytical approach to work.* Teamwork & Flexibility: A proactive team player with excellent communication skills, who can work well under pressure and is flexible with work hours to meet business needs.### Quem nós somosUm futuro mais saudável nos leva a inovar. Juntos, mais de 100 mil funcionários em todo o mundo se dedicam ao avanço da ciência, garantindo que todos tenham acesso à saúde hoje e nas próximas gerações. Nossos esforços resultam em mais de 26 milhões de pessoas tratadas com nossos medicamentos e mais de 30 bilhões de testes realizados usando nossos produtos de diagnóstico. Nós nos capacitamos para explorar novas possibilidades, promover a criatividade e manter as nossas ambições altas, para fornecer soluções de saúde que mudem a vida e causem um impacto global.Vamos construir juntos um futuro mais saudável.**A Roche é um empregador que pratica políticas de igualdade de oportunidades.**
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