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