Senior Expert - QC

SummaryPrimary responsibilities for this position include performing tasks associated with release testing and reviewing laboratory data, coordinating the team/lab under its responsibility. Communicating with internal & external partners for the Quality Control organization. Supports site as technical expert in related fieldAbout The RoleKey Responsibilities: For QC/A S and T, AS required, based upon size of site / span of Control .Coordination of departmental Operational activities (listed in QC Head role).Initiate and drive local hiring process.Line responsibility and daily walkthrough. Lead OpEx Projects.Investigation of Deviation, OOx, Complaints. Define and implement CAPAs.Support transfer Projects and validation studies.Track team metrics and ensure KQI /KPI meet requirements.Review and approve text and design. HSE incidents reporting and actionfolow up. New equipment commissioning Support (OQ, PQ).Define improvement areas in process and products. Resource and capacity (people and equipment) planning and workload management.Performance and leadership Support to specialist team.Ensure availability of equipment, chemicals and consumables, AS appropriate. SOP review and revision.Ensure training according to cGxP requirements. Exception management, Complaint Investigation Support.Ensure DI and compliance with cGxP and all regulatory requirements.Collaboration in GxP internal audits and ensure fulfillment of internal/external audit and inspection plans.Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)Essential RequirementQC of products & monitoring of processes and facilities; timely handling & settlement of deviations -Timely update of SOPs.Timely delivery of documents -Timely delivery of registration documents -Coaching tasks; compliant archiving -No avoidable safety incidents -Cost control and delivering key figures for QC with agreed timelines -Yearly training scheduleCollaborating across boundaries.Micro bio analytics/ diagnostics inc. growth propertiesQC/ QA in pharmaceutical ind./ biotech with environmental monitoring &.micro-organisms & culture media prep.cleanliness zones.Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-cultureJoin our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/networkBenefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards