1. Job Purpose
Responsible for planning, execution and control of oral liquid manufacturing, filling and packing operations to achieve production targets while ensuring compliance with cGMP, quality standards, safety requirements and approved manufacturing procedures.
2. Key Responsibilities
A. Oral Liquid Manufacturing
• Plan and execute manufacturing of syrups, suspensions, solutions, emulsions and other oral liquid formulations.
• Ensure manufacturing activities are carried out as per approved BMR/BPR, SOPs and validated processes.
• Monitor dispensing, charging, mixing, homogenization, heating/cooling, filtration and bulk transfer operations.
• Ensure proper control of critical process parameters such as mixing time, temperature, pH, viscosity, specific gravity and bulk yield, as applicable.
• Ensure appropriate hold-time controls for bulk products and intermediates.
• Review manufacturing process deviations, process failures and yield variations and initiate CAPA where required.
• Ensure line clearance, equipment status and area readiness before starting each batch.
• Coordinate with QA, QC, Engineering, Warehouse and Planning for smooth batch execution.
B. Filling Operations
• Manage liquid filling operations for bottles/containers using automatic/semi-automatic filling machines.
• Ensure correct filling volume, filling accuracy, container/closure compatibility and machine performance.
• Monitor filling line parameters and minimize rejection, leakage, spillage and product loss.
• Ensure proper cleaning, changeover and line clearance of filling equipment.
• Ensure filling equipment qualification, preventive maintenance and calibration requirements are followed.
• Investigate filling-related defects and implement corrective/preventive actions.
C. Packing Operations
• Manage primary and secondary packing operations including bottle washing, filling, capping, induction sealing, labelling, cartoning and shipper packing, as applicable.
• Ensure correct packing material, artwork, batch details, coding and reconciliation.
• Ensure proper line clearance and prevention of mix-ups and cross-contamination.
• Monitor packing line efficiency, productivity and rejection.
• Ensure reconciliation of printed and packaging materials.
• Coordinate with QA for online checks and final packing clearance.
D. Production Planning & Productivity
• Prepare daily/weekly/monthly production plans in coordination with PPC.
• Ensure achievement of production targets within planned timelines.
• Optimize manpower, machine utilization, batch cycle time and material consumption.
• Monitor OEE, yield, downtime, rejection and line efficiency.
• Identify bottlenecks and implement productivity improvement initiatives.
• Control manufacturing losses and improve overall cost effectiveness.
E. GMP & Regulatory Compliance:
• Ensure strict compliance with cGMP, GDP, data integrity and applicable regulatory requirements.
• Maintain complete and accurate batch manufacturing and packing documentation.
• Ensure adherence to SOPs, BMR/BPR, change controls, deviations, CAPA and investigation requirements.
• Support internal, customer and regulatory inspections/audits.
• Ensure proper implementation of qualification, validation and cleaning-validation requirements.
• Maintain high standards of housekeeping, personnel hygiene and safety.
F. People Management:
• Lead and develop Production Officers, Executives, Supervisors and operators.
• Plan manpower deployment across manufacturing, filling and packing activities.
• Conduct training on GMP, SOPs, safety, equipment operation and process requirements.
• Identify training needs and improve technical competency of the team.
• Promote a culture of quality, discipline, ownership and continuous improvement.
G. Cross-Functional Coordination:
• Coordinate with QA/QC for sampling, release, deviations and investigations.
• Coordinate with Engineering for equipment breakdowns, preventive maintenance and utilities.
• Coordinate with Warehouse for timely availability of raw materials and packing materials.
• Coordinate with PPC for production planning and dispatch requirements.
• Coordinate with Validation/Projects for new equipment, process validation and technology transfer activities.
3. Key Performance Indicators (KPIs):
• Production plan achievement, Batch cycle-time reduction, OEE and equipment utilization, Manufacturing and packing yield, Rejection and wastage reduction, Right-first-time batch execution, Deviation and CAPA closure, GMP compliance, Changeover time, Manpower productivity, Breakdown/downtime reduction, Audit/inspection compliance, Safety performance
4. Qualification
• B.Pharm / M.Pharm preferred.
• Candidates with relevant pharmaceutical manufacturing qualifications and strong practical experience in oral liquid production may also be considered.
5. Experience
• Manager: Approximately 8–12 years of relevant pharmaceutical manufacturing experience.
• Sr. Manager: Approximately 12–18 years of relevant pharmaceutical manufacturing experience.
• Strong hands-on experience in oral liquid manufacturing, filling and packing is preferred.
• Experience in WHO-GMP / EU-GMP / PIC/S or other regulated-market facilities will be an advantage.
6. Technical Competencies
• Oral liquid manufacturing processes, Syrup/suspension/solution manufacturing, Liquid filling and packing technology, GMP and regulatory compliance, BMR/BPR and SOP management, Deviation, CAPA and change control, Process validation and cleaning validation, Production planning and manpower management, OEE and productivity improvement, Root-cause analysis and problem solving, Equipment qualification and maintenance coordination, Strong knowledge of pharmaceutical documentation and data integrity
