Process Specialist

Band

Job Description Summary

Job Description

Major accountabilities:

Process Specialist is responsible for thedaily management of the production team in shifts and ensures that manufacturing activities are executedsafely, efficiently and according to plan, in full compliance withHSE and GMP requirements.

This role combines:

• People management
• Operational coordination
• Quality oversight
• Continuous improvement

within aregulated manufacturing environment

• Providefrontline technical support for process-related issues in daily manufacturing operations
• Support the manufacturing team during:
  • New product introduction
  • Process changes
• Drivecontinuous improvement initiatives to enhance quality and productivity
• Ensure strict adherence tosafe 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
• Supportregulatory inspections and audits, ensuring consistency between manufacturing practices and documentation

• Lead, coach, and motivate the production team during the shift; act as thefirst point of contact on the shop floor
• Establish and monitorclear task allocation, including:
  • Staffing levels
  • Break planning
  • Absence management
  • Shift organization
• Overseeproduction 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 ofoperational or technical issues to ensure production continuity
• Contribute totalent 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

• Minimum2 years of relevant experiencein amanufacturing 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 withdiverse teams
• Good command ofEnglish(for communication and documentation)
• Ability and willingness to work withEnglish 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