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Quality Team Leader QA Operations (m/f/d)



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Operations, Quality Assurance
Posted on Wednesday, January 24, 2024

About the Role

Quality Team Leader QA Operations (m/f/d), Drug Substance, Schaftenau

As Quality TL QA Operations you will be providing the Leadership in all quality related matters to ensure that all aspects of the operational business comply with cGMP (Current Good manufacturing Practices) legal and regulatory requirements and the Novartis Quality Manual & Policies. You will be ensuring that all products manufactured by site/External Supplier in addition to the imported products for local site are released to the market according to Novartis Quality Standards.

Your key responsibilities:

Your responsibilities include, but are not limited to:

• Oversight of Quality Operations across site; MBR review and approval; product release
• QA for Quality Control and AS and T; QA Operational Excellence; line responsibility and daily walkthrough; lead OpEx Projects; Investigation of Deviation, OOx, Complaints
• Define and implement CAPAs; support transfer Projects & validation studies; track team metrics and ensure KQI /KPI meet requirements
• HSE incidents reporting and action follow up; new equipment commissioning Support (OQ, PQ); define improvement areas in process and products; ensure availability of equipment, chemicals and consumables, AS appropriate; SOP review and revision
• Resource and capacity (people and equipment) planning and workload management; performance and leadership Support to specialist team; initiate and drive local hiring process; ensure onboarding and training of new team members and provide similar support to new team members of other teams as appropriate; perform local training and monitor training status
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt; distribution of marketing samples (where applicable)
• Target / KPI setting according to the global target letter; no KPI misses caused by QA Operations
• Participate in and ensure implementation of efficiency and saving projects; ensure timely batch release in the responsibility of QA Operations and participate in continuous improvement projects to shorten the overall batch release through put time

This job is no longer accepting applications

See open jobs at Novartis.