Resumen
About the Role
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
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-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
