Process Specialist

TR01 (FCRS = TR001) Novartis Sağlık, Gıda ve Tarım Ürünleri San. Ve Tic. A.Ş.; Pendik; On-site; TRY 300,000 - 450,000; Full time

Job summary

Novartis Sağlık, Gıda ve Tarım Ürünleri San. Ve Tic. A.Ş. in Pendik, Türkiye is hiring a Process Specialist to oversee daily production activities, ensure GMP and HSE compliance, and provide frontline technical support for manufacturing processes.

The role emphasizes people management, shift coordination, quality oversight, and continuous improvement initiatives across functions to deliver safe, compliant, and efficient production.

Qualifications

• Minimum 2 years of relevant experience in a manufacturing environment.
• Technical education or equivalent manufacturing experience.
• Knowledge of GMP Quality systems and compliance requirements.
• Strong communication skills and English documentation experience.
• Ability to work in shifts with diverse teams.

Responsibilities

• Manage daily production team activities across shifts.
• Ensure safety, GMP, SOP compliance and quality oversight.
• Lead continuous improvement initiatives and Kaizen.
• Coordinate with cross-functional teams for deviations and CAPA actions.
• Provide frontline technical support for process issues.

Skills

Team coordination

People management

Performance monitoring

Analytical skills

Problem solving

Communication skills

Shift work

Collaboration skills

Data analytics

Digital skills

Resilience

Education

Technical education or equivalent manufacturing experience; Pharmaceutical /Chemical

Tools

WERUM PAS-X MES

SAP S4HANA

Serialization (OPTEL)

Aggregation (AGE)

Job description

Job Description Summary

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

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.