Process Specialist

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