Daily Production Supervision: Plan coordinate and execute daily manufacturing schedules for OSD operations (dispensing granulation compression coating and capsule filling) to hit target volume metrics safely and on time.
cGMP & Regulatory Compliance: Ensure all manufacturing steps strictly comply with current Positive Manufacturing Practices (cGMP) standard operating procedures (SOPs) and international regulatory guidelines (USFDA EMA WHO).
Batch Documentation & Review: Oversee the error-free execution of Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) conducting timely technical reviews prior to Quality Assurance (QA) release.
Shift & Team Leadership: Lead train and mentor production supervisors team leaders and operators managing shift rosters workload distribution and performance evaluations.
Deviation & CAPA Management: Lead investigations into shop-floor deviations out-of-specification (OOS) events and equipment failures; design and implement robust Corrective and Preventive Actions (CAPA).
Yield & Operational Excellence: Monitor material usage yield reconciliation and batch productivity leading Lean Manufacturing/Six Sigma initiatives to minimize cycle times scrap and material wastage.
Equipment Maintenance & Qualification: Collaborate with Engineering and Validation teams for scheduled maintenance calibration and IQ/OQ/PQ qualifications of core OSD equipment (e.g. fluid bed dryers rotary tablet presses capsule fillers).
Audit Readiness: Drive continuous audit readiness across the manufacturing plant participating actively in external regulatory inspections and internal quality audits.
EHS & Shop-Floor Safety: Enforce strict Environmental Health & Safety (EHS) policies ensuring proper containment protocols for high-potency APIs use of Personal Protective Equipment (PPE) and ergonomic compliance.