Process Specialist

Job Description Summary

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