Process Specialist
Sandoz · Gebze
Job Description Summary
-Shift Lead II -The Shift Leader is responsible for managing his team to carry out the manufacturing operations according to schedule in compliance with HSE and GMP rules. -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. -Operational Scheduler -The Operational Scheduler establishes and maintains an up-to date a detailed plan for Manufacturing Unit-related activities. The Operational Scheduler is responsible to develops different production scenarios (run rate increase, process changes, ramp-up, shift model adaptation etc.) as well as improving the scheduling tool. -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. -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:
- Shift Lead II -Represent production management to the team members and promote Sandoz values within the team -Line responsibility and shift walkthrough -Engage and motivate the team and delivers strong results with an empowered team -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 Operation Scheduler -Is responsible to provide a feasible plan to the shop floor in terms of materials and capacity availability -Establish optimized sequence of orders within the Planning Time Fence and keep it up to date, based on rules agreed by manufacturing, Quality and other support functions and in accordance with Customer requirements -Provide the planning status in the daily production meeting -Manufacturing Systems Expert -Define User requirement specifications (Voice of customer) -Design and create electronic batch files (EBR) with respect for quality, costs and deadlines -MBR / BOM/ Recipe creation in production IT systems -Participate in the qualification and risk assessment processes -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 -HSE and Quality -Promote and improve the HSE culture, by implementing the necessary systems and actions in line with the evolution of the site -Promote and improve the Quality culture in collaboration with Quality Assurance.
- Ensure overall inspection readiness for area of responsibility -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, technical training program in place and executed, training data, attracting and retaining talent, succession plan for Manufacturing team in place and robust.
- HSE: amount of work accidents with work disability
Minimum Requirements:
Work Experience:
- People Challenges.
- Major Change.
- Functional Breadth.
- Operations Management and Execution.
- Collaborating across boundaries.
- Project Management.
Skills:
- Change Control.
- Chemical Engineering.
- Continual Improvement Process.
- Efficiency.
- Employment Discrimination.
- Flexibility.
- General Hse Knowledge.
- Good Documentation Practice.
- Knowledge Of Capa.
- Knowledge Of Gmp.
- Lean Manufacturing.
- Manufacturing (Production).
- Manufacturing Process.
- Physics.
- Process Control.
- Production Line.
- Productivity.
- Risk Management.
- Root Cause Analysis (Rca).
- Scheduler.
- Technology Transfer.
- Well-Being.
Languages :
- English.
Skills Desired
Change Control, Chemical Engineering, Continual Improvement Process, Efficiency, Employment Discrimination, Flexibility, General Hse Knowledge, Good Documentation Practice, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Physics, Process Control, Production Line, Productivity, Risk Management, Root Cause Analysis (RCA), Scheduler, Technology Transfer, Well-Being