Pharmaceutical Process Expert

A. Job Purpose
• This role reports directly to the HCMC Operational Excellence Manager of Opella.
• The Process Expert is accountable for qualifying and stabilizing production processes, developing standards, and driving continuous improvement initiatives. Ensure compliance with regulation, GMP and HSE through process optimization and data-driven decision-making.
• This is key position for problem solving of process/production deviation.
• This role is to manage upstream processes at Solid workshop
B. Key working relationships:
Internal:
• Operational Excellence Manager - Direct reporting and alignment on improvement priorities.
• APU Manager - Coordinate on process implementation and troubleshooting.
• QA/QC - Ensure process compliance and resolve quality issues.
• Engineering & Maintenance - Collaborate on equipment-related process improvements.
• Digital/Data Team - Align on KPI tracking and digitalization projects.
• TTI - key contact for launching projects
• KSOL - key contact for MSEP initiatives
• ME - key contact for process improvement
External:
• Regulatory Auditors - Provide process documentation and support during audits.
• Technology Vendors - Assist in implementing process automation and digital tools.
C. Key Accountabilities
Focus: Process optimization, cost efficiency, compliance, data and technology.
Process Stabilization & Standardization
• Develop and maintain SOPs and process standards in compliance with GMP/ HSE.
• Monitor process performance and implement corrective actions.
Continuous Improvement
• Identify opportunities, propose initiatives for efficiency gains and cost reduction.
• Support Lean, Six Sigma, and OPS programs at the workshop level.
Data Analysis & KPI Monitoring
• Collect and analyze production data to identify trends and deviations.
• Provide insights to improve productivity and reduce variability.
Project Support
• Participate in new product launches, compliance upgrades, and improvement projects on behalf of production and transfer to APU.
• Coordinate with EM and QA team to implement the qualifications and lead the training, documentation, standardization at production to meet the user requirement and transfer to APU.
Compliance & Audit
• Prepare process-related documentation and support internal/external audits.