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's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.The PositionAt Roche Pharma Malaysia, we are seeking a Quality Assurance Specialist to play a crucial role in ensuring the highest standards of quality throughout our operations. This role is reporting to Quality Assurance Lead.By overseeing batch release, managing local redressing activities, handling returns and write-offs, and resolving quality-related complaints, you will contribute to our mission of delivering safe and effective pharmaceutical products to our customers.Your commitment to maintaining compliance with regulatory systems and driving continuous improvement will enhance our reputation as a trusted provider of high-quality medications.Through collaboration with third-party providers, meticulous data entry, and efficient file management, you will contribute to the seamless execution of our regulatory activities and ensure accurate product information updates.As the owner of SOPs, you will have a direct impact on our processes, promoting consistency and excellence in our operations.With your decision-making authority, you will play a critical role in upholding our commitment to quality in all aspects of our work.Join us in this impactful role and help us make a difference in the lives of patients.As qualified Quality Assurance Compliance and Operations, you will:Responsible for quality assurance operational activities including managing batch release activities for incoming shipments, local redressing activities, trade returns and write offs, quality related complaints or enquiries and product recall. Work closely with appointed third party service providers and resolve any operational related issues in a timely manner. Responsible for maintaining compliance to the Pharmaceutical Management System (PQS) and Regulatory Compliance System, and supporting compliance activities by driving innovation and continuous improvementInformation and Documentation Management:Ensure accurate, timely and thorough data entry for Affiliate regulatory activities on relevant Roche systemsManage product information updates with respect to Roche and local regulatory requirements and for Roche databasesEnsure files are managed properly and archive documents are complete and easily retrievedGood housekeeping of Quality Assurance areas and inventory, including Filing RoomsResponsible and accountable to ensure SOP is updated as per required on a timely mannerClearance from Quality Assurance Lead is required for all matters related to quality matters, except routine on-going activitiesExpertise:Experience in a Quality Assurance role in a pharmaceutical environment for 1-3 years is a plusKnowledgeable in GxP requirements, in particular, GMP, GDP and GDPMDFluency in written and spoken English and Bahasa MalaysiaProficient in basic computer software/applicationsCompetencies & Education / Qualifications:Demonstrate Roche Core CompetenciesIntegrityGood analytical, problem-solving and decision making skillsDetailed-oriented with a focus on accuracy and precisionBuilds truthful and effective relationships with stakeholdersCommitment to performance measures of time, cost and qualityCommunication Skills: strong interpersonal skills to influence individuals or groups at more than one level who may have different interests or goals to reach consensus and achieve team objectives. Takes responsibility, drives results and achieves expected outcomesDegree in chemistry or science-related fieldTrained in GMP, GDP and GDPMD requirements for pharmaceuticals and medical devicesWho we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.Roche is an Equal Opportunity Employer.
