Job Description
Job description Job Location: Ahmedabad Role & responsibilities of Process Excellence Reviewer: PRINCIPAL DUTIES AND RESPONSIBILITIES: Execute operational excellence projects and continuous improvement initiatives across clinical research processes. Plan and conduct process excellence (PE) checks, inprocess, gamba walk, retrospective, internal, external, and unannounced visits based on master study schedules, riskbased approaches, Periodic system oversight/assessment and ensure sponsorspecific requirements. Collaborate with crossfunctional teams to identify process optimization opportunities and implement innovative, compliant solutions aligned with organizational goals. Develop, review, and maintain process workflows; identify gaps, inefficiencies, and bottlenecks related to quality, training, cost, and timelines. Monitor processes across multiple Cliantha locations and ensure harmonization and standardization of practices. Communicate process enhancements and improvement recommendations to users as part of a continuous improvement program. Apply Lean, Six Sigma, or similar methodologies, where applicable, to ensure consistent process quality. Ensure all improvement initiatives adhere to applicable GxP, safety, data integrity and regulatory requirements. Skills: Continuous improvement & lean methodology Good communications skills with the cluster head Proficiency in using data-driven methodologies to analyze process performance, identify trends, and translate complex data sets into actionable operational improvements. Evidence-Based Decision Making Practical application of the DMAIC (Define, Measure, Analyze, Improve, Control) framework. Lean Six Sigma Green Belt/ Black Belt methodology (encouraged) Experience Required: Should have 4-5 years of relevant experience in clinical research industry, Quality Assurance experience in clinical trials/Bioequivalence studies is preferred. Role: Other Industry Type: Clinical Research / Contract Research Department: Other Employment Type: Full Time, Permanent Role Category: Other Education UG: B.Pharma in Any Specialization PG: M.Pharma in Any Specialization Key Skills Skills highlighted with ‘‘ are preferred keyskills Clinical Research ICH-GCPCRFQuality Assurance
