cGMP & GDP Enforcement: Ensure strict adherence to Current Good Manufacturing Practices and Good Documentation Practices across all batch records and logbooks.
Daily Floor Supervision: Oversee daily shift operations, line clearances, and workflow execution across OSD, aseptic fill-finish, or bioprocess suites.
Apprentice & Operator Coaching: Deliver structured on-the-job training (OJT) to apprentices and technicians, signing off on core technical competencies.
Deviation & RCA Handling: Identify operational anomalies, raise non-conformance reports, and assist with Root Cause Analysis (RCA) and CAPA execution.
Cleanroom & EHS Management: Enforce strict cleanroom discipline, environmental monitoring protocols, and Environmental Health and Safety (EHS) guidelines.
Shift Handover & Scheduling: Manage shift handovers, line assignments, and daily production schedules to meet yield and throughput targets.
Batch Record Review: Perform real-time audits of Batch Production Records (BPRs) to catch and correct documentation errors immediately.
Continuous Improvement: Apply Lean/Six Sigma practices to optimize changeover times, reduce waste, and improve overall equipment effectiveness (OEE).
Audit Readiness: Maintain constant facility readiness for internal quality checks and regulatory inspections (e.g., FDA, EMA, MHRA).
