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?

Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)