Process Specialist

Band

Level 3

Job Description 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

Job Description

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)

Skills Desired

Business Processes, Data Analytics, digital skills (Inactive), General Hse Knowledge (Inactive), Good Manufacturing Practices (GMP), Resilience