Senior Expert

2 days ago


Tuas, Singapore c14825db-5220-441e-9414-9c23728402a4 Full time $150,000 - $180,000 per year

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:

  • QC 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 schedule
  • Collaborating across boundaries.
  • Micro bio analytics/ diagnostics inc. growth properties
  • QC/ QA in pharmaceutical ind./ biotech with environmental monitoring &.
  • micro-organisms & culture media prep.
  • cleanliness zones.

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