Job Description

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people\xe2\x80\x99s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.The PositionQuality Assurance SpecialistA healthier future. It\xe2\x80\x99s 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\xe2\x80\x99s what makes us Roche.As a Quality Assurance Specialist, you will implement and maintain robust Quality Assurance (QA) systems to ensure the highest standards of product quality. You are responsible for executing GMP and GDP activities for Singapore Affiliate operations in accordance with quality requirements and contribute to the mission of delivering safe and effective pharmaceutical products to customers, ensuring compliance with regulatory standards and driving continuous improvement. This role is crucial in maintaining our license to operate and enhancing our reputation as a trusted provider of high-quality medicationsYour opportunityPerform batch record review and release drug product, including temperature excursion and product damages evaluationCollaborate with other departments to provide quality expertise in daily operationsManage vendor and measure performance metrics related to batch record and ensure all secondary assembly activities comply with specifications and regulatory requirementsManage change controls according to Standard Operating Procedures (SOP)Investigate and resolve deviations, product complaints, and counterfeit incidents promptly, following SOPs as well as review and update QA SOPs to align with the Global Pharma Quality System and local regulations (GDP/GMP)Assist in product destruction, return goods disposition, and product recallsSupport Management Review, Quality Risk Management and participate in internal and external audit as neededContribute to quality-related projects during implementation and operational stages, fostering innovation and continuous improvementWho you areDegree in Science discipline with more than 2 years of QA experience in the pharmaceutical industryTrained with GMP/GDP requirements for pharmaceutical industryExperience engaging with internal stakeholders (e.g., Regulatory, Supply Chain, Commercial Team) and external partners (e.g., health authorities, third-party distributors, distribution hubs)Experience in batch release, quality event management, and audits with in-depth understanding of GMP/GDP requirementsHas strong organizational and planning skills and committed to ethical standards and integrity with the ability to influence and drive changeHas excellent communication, interpersonal and networking skills and dedicated to achieve key performance metrics related to time, cost, and qualityCapacity to engage teams and coordinate quality assurance initiatives and has an agile mindset with a focus on continuous learning and growthWho we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we\xe2\x80\x99ve become one of the world\xe2\x80\x99s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.Roche is an Equal Opportunity Employer.

Roche