QC and AS&T Lead

Major Accountabilities:

• 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 action follow 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.
• Perform local training and monitor training status for Microbiological QC as above, plus: management of Microbiological activities in Line with site objectives.
• Ensure training according to cGxP requirements.
• Management of documentation and Methods according to cGxP.
• 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.
• Equipment qualification review /release.
• Ensure activities executed according to cGxP standars planning, Collaboration in GxP audits/inspections.
• Ensure Methods and Procedures are up to date.
• Management of documentation and Methods according to cGxP.
• Ensure qualification /calibration status of analytical equipment.
• Ensure compliance of products and other materials with specifications and with corporate, health authorities, and E5 requirements.
• Microbiological testing review and approval.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
• Distribution of marketing samples (where applicable)

Key Performance Indicators:

• 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