Process Specialist

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
Data Analytics, digital skills, General Hse Knowledge  , gmp knowledge, process excellence, Resilience