Process Specialist

Job description

Job Description

SummaryYou 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 initiativesThis position requires close collaboration across multiple functions to:
• Strengthen quality standards, productivity, and compliance
• Contribute to a safe and high-performing operational cultureMajor 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 managementOperational coordinationQuality oversightContinuous improvementwithin a regulated manufacturing environmentProvide frontline technical support for process-related issues in daily manufacturing operationsSupport the manufacturing team during: New product introductionProcess changesDrive continuous improvement initiatives to enhance quality and productivityEnsure strict adherence to safe and compliant execution of production activities in line with: Production plansGood Manufacturing Practice (GMP)Standard Operating Procedures (SOPs)

HSE guidelinesInternal guidelinesCollaborate closely with cross-functional teams to: Manage quality deviationsImplement corrective actionsSupport regulatory inspections and audits, ensuring consistency between manufacturing practices and documentationLead, coach, and motivate the production team during the shift; act as the first point of contact on the shop floorEstablish and monitor clear task allocation, including: Staffing levelsBreak planningAbsence managementShift organizationOversee production quality and documentation, including: Batch record reviewLogbooksAdministrative follow-upSupport management of: DeviationsComplaintsOOS (Out-of-Specification)OOE (Out-of-Expectation)CAPA actionsand collaborate with relevant stakeholders during investigationsEscalate and support resolution of operational or technical issues to ensure production continuityContribute to talent development, including: TrainingCoachingPerformance managementSuccession planningActively contribute to: Continuous improvementEfficiency gainsAudit readinessCross-team collaborationManage

Tier-1 meetings with shift operators prepare and distribute shift reports.Provide front line expert support for all process-specific issues to productionKey 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 targetsAdherence to the GMP and HSE rulesEssential RequirementsMinimum
• 2 years of relevant experience in a manufacturing environmentTechnical education or equivalent industrial manufacturing experience;Pharmaceutical /Chemical manufacturing processesEquipment used in production5S & Lean Production and Kaizen KnowledgeStrong knowledge of:GMPQuality systemsCompliance requirementsStrong analytical and problem-solving skillsStrong Communication SkillsAbility to work in shifts effectively with diverse teamsGood command of English (for communication and documentation)Ability and willingness to work with English documentationProven experience in: Team coordinationPeople managementPerformance monitoringStrong focus on: QualitySafetyCollaborationSkills: Data AnalyticsDigital skillsGeneral HSE Knowledge GMP KnowledgeProcess excellenceResilienceLanguages: EnglishTurkish (Local Language)