Job Description Summary
-Process Team Lead Medium/Small Site Oversees the daily operation within the Manufacturing Unit, in a way that is consistent with a culture of self-direction (empowerment and accountability), to produce and deliver high quality products to customers in a compliant, efficient, and cost effective manner. -Process Support Unit Lead Medium/Small SiteLead the process unit team in coordinating and planning of all activities with end-to-end manufacturing responsibility (logistics, project work, operational excellence, resources and budget/costs) in a way that is consistent with a culture of self-direction (empowerment and accountability). Ensures full compliance with quality, Health, Safety and Environment (HSE), Good Manufacturing Practices (GMP), customer service, statutory, regulatory and Sandoz requirements. -Senior Process Expert -Provide front line technical and scientific expert support for all process-specific issues to ensure execution of processes on-time (business continuity); in compliance to cGMPs, SOPs and applicable guidelines and functional standards (e.g. HSE, NOSSCE) and to allow continuously improving in quality, productivity efficiency. -Manufacturing Systems Lead / Senior Manufacturing Systems Expert MES Expert providing technical expertise in support of all issues linked to electronic batch records (eBRs). MES Expert supporting MES deployment, implementation and continuous improvement in the Manufacturing Units and providing shop floor routine technical support. MES Lead coordinating and managing Manufacturing System Experts team. Manage complex and integrated manufacturing execution systems (MES/SAP/LS…). Complex programming for complex manufacturing processes -Senior Technical Trainer -Delivers technical training and assessed learning outcomes for the assigned scope. May also design and develop learning interventions. May also lead training audit response for site.
Job Description
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, Sandoz quality/safety policies, and the standards and quality/safety procedures -Guarantee the effectiveness of the Business Continuity Plan -Ensure the application of Sandoz data integrity standards, CSV, and IGM in projects -Reporting of technical complaints / adverse events / special case scenarios related to Sandoz 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:
- Major Change.
- People Challenges.
- Collaborating across boundaries.
- Operations Management and Execution.
Skills:
- Assembly Language.
- Change Control.
- Chemical Engineering.
- Chemistry.
- Continual Improvement Process.
- Efficiency.
- General Hse Knowledge .
- Good Documentation Practice.
- Knowledge Of Capa.
- Knowledge Of Gmp.
- Lean Manufacturing.
- Manufacturing (Production).
- Manufacturing Process.
- Process Control.
- Productivity.
- Risk Management.
- Root Cause Analysis (Rca).
- Scheduler.
- Six Sigma.
- Sop (Standard Operating Procedure).
- Team Work.
- Technology Transfer.
- Web Methods Flow.
Languages :
Skills Desired
Assembly Language, Change Control, Chemical Engineering, Chemistry, Continual Improvement Process, Efficiency, General Hse Knowledge , Good Documentation Practice, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Process Control, Productivity, Risk Management, Root Cause Analysis (RCA), Scheduler, Six Sigma, Sop (Standard Operating Procedure), Team Work, Technology Transfer, Web Methods Flow
