Process Specialist

Summary Job Description Summary

You will have the opportunity to apply your expertise at the frontline of delivering high-quality pharmaceutical products to patients.

As a Process Specialist, you will play a central role in Novartis manufacturing operations by:

• Supporting daily production activities
• Solving process-related issues
• Driving continuous improvement initiatives

This Position Requires Close Collaboration Across Multiple Functions To

• Strengthen quality standards, productivity, and compliance
• Contribute to a safe and high-performing operational culture

About The Role Major accountabilities: Process Specialist is responsible for the daily management of the production team in shifts and ensures that manufacturing activities are executed safely, efficiently and according to plan , in full compliance with HSE and GMP requirements .

This Role Combines

• People management
• Operational coordination
• Quality oversight
• Continuous improvement

within a regulated manufacturing environment

• Provide frontline technical support for process-related issues in daily manufacturing operations

• Support the manufacturing team during:

• New product introduction

• Process changes

• Drive continuous improvement initiatives to enhance quality and productivity

• Ensure strict adherence to safe and compliant execution of production activities in line with:

• Production plans

• Good Manufacturing Practice (GMP)

• Standard Operating Procedures (SOPs)

• HSE guidelines

• Internal guidelines

• Collaborate closely with cross-functional teams to:

• Manage quality deviations

• Implement corrective actions

• Support regulatory inspections and audits, ensuring consistency between manufacturing practices and documentation

• Lead, coach, and motivate the production team during the shift; act as the first point of contact on the shop floor

• Establish and monitor clear task allocation, including:

• Staffing levels

• Break planning

• Absence management

• Shift organization

• Oversee production quality and documentation, including:

• Batch record review

• Logbooks

• Administrative follow-up

• Support management of:

• Deviations

• Complaints

• OOS (Out-of-Specification)

• OOE (Out-of-Expectation)

• CAPA actions and collaborate with relevant stakeholders during investigations

• Escalate and support resolution of operational or technical issues to ensure production continuity

• Contribute to talent development, including:

• Training

• Coaching

• Performance management

• Succession planning

• Actively contribute to:

• Continuous improvement

• Efficiency gains

• Audit readiness

• Cross-team collaboration

• Manage Tier-1 meetings with shift operators prepare and distribute shift reports.

• Provide front line expert support for all process-specific issues to production

• Key user responsibilities for all Manufacturing Systems (WERUM PAS-X MES, SAP S4HANA, Serialization (OPTEL) & Aggregation (AGE)

• 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 Schedule.

Key Performance Indicators

• Achieve plant KPIs , (PSP, Volume, BOMA, ROA, On time Compliance Activities, TPT, On Batch Record Review and Deviation Management , POV )
• Adherence to the production plan, achieving line OAEs and yield targets
• Adherence to the GMP and HSE rules

Essential Requirements

• Minimum 2 years of relevant experience in a manufacturing environment

• Technical education or equivalent industrial manufacturing experience;

• Pharmaceutical /Chemical manufacturing processes

• Equipment used in production

• 5S & Lean Production and Kaizen Knowledge

• Strong knowledge of:

• GMP

• Quality systems

• Compliance requirements

• Strong analytical and problem-solving skills

• Strong Communication Skills

• Ability to work in shifts effectively with diverse teams

• Good command of English (for communication and documentation)

• Ability and willingness to work with English documentation

• Proven experience in:

• Team coordination

• People management

• Performance monitoring

• Strong focus on:

• Quality

• Safety

• Collaboration

Skills

• Data Analytics
• Digital skills
• General HSE Knowledge
• GMP Knowledge
• Process excellence
• Resilience

Languages

• English
• Turkish (Local Language)

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.

Read our handbook (PDF 30 MB)