Job Description

About Client: Top 10 Pharma company
Position Overview
We are seeking a highly motivated Operational Excellence (OPEX) Manager to drive process improvements, efficiency, and compliance across Oral Solid Dosage (OSD) formulation manufacturing operations. The role will focus on implementing lean methodologies, optimizing resource utilization, and ensuring adherence to regulatory standards, while fostering a culture of continuous improvement.
Key Responsibilities
Operational Excellence
Lead OPEX initiatives across OSD formulation units to improve productivity, reduce costs, and enhance quality.
Implement Lean, Six Sigma, and Kaizen practices to streamline manufacturing processes.
Identify bottlenecks and drive root cause analysis with cross-functional teams.
Develop and monitor KPIs for operational efficiency and sustainability.
Process Optimization
Standardize manufacturing workflows for granulation, compression, coating, and packaging.
Support technology transfer and scale-up activities with a focus on efficiency and compliance.
Drive digitalization and automation projects to enhance operational performance.
Compliance & Quality
Ensure all OPEX initiatives align with cGMP, EU, and USFDA regulatory requirements.
Collaborate with QA/QC teams to maintain high-quality standards.
Support audit readiness and documentation for regulatory inspections.
Training & Change Management
Conduct training sessions for plant staff on Lean and OPEX tools.
Promote a culture of continuous improvement and employee engagement.
Facilitate workshops to encourage idea generation and problem-solving.
Cross-Functional Collaboration
Work closely with Production, Engineering, Supply Chain, and Quality teams.
Partner with leadership to align OPEX projects with strategic business goals.
Provide regular updates and reports to senior management on project outcomes.
Qualifications & Skills
Bachelor's/Master's degree in Pharmacy, or related discipline.
6-10 years of experience in OSD formulation manufacturing with exposure to OPEX/Lean projects.
Certified Lean Six Sigma Green Belt/Black Belt preferred.
Strong knowledge of OSD processes (granulation, compression, coating, packaging).
Excellent analytical, problem-solving, and project management skills.
Proficiency in data analysis tools and MS Office.

Skills Required