Shift Leader

Sandoz; Gebze; On-site; TRY 350,000 - 520,000; Full time

Job summary

Sandoz in Gebze, Turkey is seeking a Senior Process/Manufacturing Specialist to lead process teams and manage line responsibilities on a medium/small site. You will ensure production schedules align with planning, GMP, SSE, and 5S compliance, and translate strategic objectives into actionable plans.

Role requires experience in pharmaceutical manufacturing, regulatory CSV considerations, and training program delivery. English fluency is required and a strong Lean/Six Sigma mindset is beneficial.

Qualifications

• Experience in pharmaceutical manufacturing and quality systems.
• Knowledge of GMP/HSE policies and data integrity standards.

Responsibilities

• Coordinate production operations to comply with documentation and GMP rules.
• Lead process teams and manage resource allocation and task prioritization.
• Deliver technical training programs and support qualification of associates.

Skills

English

Assembly Language

Change Control

Chemical Engineering

Chemistry

Continual Improvement

Documentation Practice

GMP Knowledge

Capa Knowledge

Lean Manufacturing

Manufacturing

Process Control

Six Sigma

SOPs

Quality/Training

Web Methods Flow

Tools

Sandoz systems knowledge

Job description

• 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)

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

• English.