June 26, 2024

Sandoz

Gebze

OTHER

Manufacturing system lead

Major accountabilities:

Process Team Lead Medium/Small Site -Line responsibility and daily walkthrough -Ensures shop floor resource planning is adequate in correlation with production workload Vs planning -Reviews production schedule (operational horizon) taking into account risks, constraints and opportunities -Process Support Unit Lead Medium/Small Site -Translates the strategic objectives of his team into detailed objectives and action plans -Manage resource and task allocation within the team -Arbitrate tasks prioritization -Senior Process Expert -Provide front line expert support for all process-specific issues to production -Act as Subject Matter Expert (SME) for the product and process -Coordinate and ensure the completion of all production operations on time, in accordance with the documentation and in compliance with GMP, SSE and 5S rules -Manufacturing Systems Lead / Senior Manufacturing Systems Expert -Define User requirement specifications (Voice of customer) -Design and create electronic batch files (EBR) with respect for quality, costs and deadlines -Deep understanding of Manufacturing/automation/programming/CSV qualification -Good understanding of regulatory manufacturing execution systems CSV requirements across multiple health authorities -Senior Technical Trainer -Delivers engaging technical training programs, using multiple delivery methodologies (OJT, Classroom, virtual classroom etc.) to support qualification of associates to perform technical tasks and develop technical capabilities -Design and develop technical training programs, aligned with the site strategy and local training plans -Present site training strategy and respond to auditor questions -Specific certification, qualification on systems, processes, etc. -Coaching, facilitation, consulting and trainer skills and qualification -Certification on internal auditor etc..
Experience at pharmaceutical industry And manufacturing -HSE and Quality -Guarantee the conformity of the manufacturing unit activities with regard to GMP and HSE rules, Novartis quality/safety policies, and the standards and quality/safety procedures -Guarantee the effectiveness of the Business Continuity Plan -Ensure the application of Novartis data integrity standards, CSV, and IGM in projects -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:

Achieve plant KPIs -Human Resources Performance: Satisfaction survey, execution of Talents and development plans, training data, attracting and retaining talent, succession plan for Support team in place and robust.
Batch success rate -Launch performance on time -Success rate internal/External and GMP audits/inspections

Minimum Requirements:
Work Experience: