Production Operations

• Execute the daily/weekly production plan; balance manpower and machine capacity to meet schedule adherence.
• Perform line start-up, changeover, and shutdown per approved SOPs; minimize changeover and unplanned downtime.
• Monitor critical process parameters (e.g., mixing time, compression force, coating conditions, fill volumes) and make in-process adjustments within approved ranges.
• Verify availability and status of materials, components, and tooling; escalate shortages or quality issues promptly.

GMP & Compliance

• Enforce GMP, Data Integrity, and GDP across all line activities.
• Ensure batch records, logbooks, and electronic entries are complete, legible, and error-free.
• Lead/participate in investigations for deviations, OOS/OOT, line incidents; implement effective CAPAs.
• Maintain line clearance, cleanliness, and status labeling; manage segregation and traceability of materials.
• Support qualifications/validations (DQ/IQ/OQ/PQ), change controls, and periodic requalification as applicable.

People Leadership

• Supervise and develop operators/technicians (typically 8–25 staff).
• Plan shifts, rotations, and overtime; ensure skills coverage for critical tasks.
• Conduct on-the-job training and routine competency assessments; maintain training matrices.
• Give clear daily briefs, set expectations, and coach for performance and behavior.

• Bachelor’s degree in Pharmacy, Chemical/Process/Industrial Engineering, or related field.
• At least 2 years experience in GMP pharmaceutical manufacturing (solids, liquids, creams/ointments, or packaging).
• Working knowledge of WHO GMP / PIC/S, GDP, Data Integrity, and ISO 9001 principles.
• Familiarity with validation/change control, and basic cleanroom/HVAC concepts (pressure differentials, filtration).
• Experience with ERP/MES/LIMS and basic SPC preferred.