Senior Expert - QC

Summary

Primary 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 field

About the Role

Key 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 Requirement :

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?

Join 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 :

Benefits and Rewards : Read our handbook to learn about all the ways we’ll help you thrive personally and professionally :

DivisionOperationsBusiness UnitQualityLocationSingaporeSiteTuas South AvenueCompany / Legal EntitySG12 (FCRS = SG012) Novartis Singapore Pharmaceutical Manufacturing Pte LtdFunctional AreaQualityJob TypeFull timeEmployment TypeRegularShift WorkNo

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

#J-18808-Ljbffr