Senior Chemical Engineer - Process Development & GMP Compliance
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仕事内容
Lead design, analysis, and optimization of pharmaceutical manufacturing processes (formulation, mixing, granulation, coating, and sterilization) to improve yield, efficiency, and scalability.
Drive process development and improvement projects from concept through implementation using structured problem-solving (RCA, 5 Whys, Fishbone, FMEA).
Collaborate with Production, Quality, Validation, Engineering, Maintenance, and R&D to ensure robust, compliant processes.
Analyze process data and KPIs to support continuous improvement and risk reduction while identifying bottlenecks and optimization opportunities.
Ensure all process changes comply with GMP, quality standards, and regulatory requirements; participate in internal and external audits.
Assist with validation activities and regulatory inspections; apply statistical methods (Cp, Cpk) and advanced Excel tools for data-driven decisions.
Drive process development and improvement projects from concept through implementation using structured problem-solving (RCA, 5 Whys, Fishbone, FMEA).
Collaborate with Production, Quality, Validation, Engineering, Maintenance, and R&D to ensure robust, compliant processes.
Analyze process data and KPIs to support continuous improvement and risk reduction while identifying bottlenecks and optimization opportunities.
Ensure all process changes comply with GMP, quality standards, and regulatory requirements; participate in internal and external audits.
Assist with validation activities and regulatory inspections; apply statistical methods (Cp, Cpk) and advanced Excel tools for data-driven decisions.
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