Summary
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:
- 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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