1. Production Planning and Execution

- Prepare daily, weekly, and monthly production plans as per the production schedule.

- Ensure timely manufacturing of tablets, capsules, and other OSD products.

- Allocate manpower, machines, and resources according to production requirements.

- Monitor production activities to achieve planned production targets.

- Ensure minimum production downtime and optimum utilization of resources.

- Coordinate with the planning department for batch priorities.

1. Manufacturing Operations

- Supervise all OSD manufacturing activities, including:

- Dispensing and weighing of raw materials.

- Sifting and screening.

- Granulation (Wet and Dry Granulation).

- Drying and milling.

- Blending and lubrication.

- Tablet compression.

- Capsule filling.

- Coating.

- In-process checks.

- Ensure manufacturing activities are performed according to approved Batch Manufacturing Records (BMR).

- Monitor critical process parameters (CPPs) during manufacturing.

- Ensure compliance with approved manufacturing procedures and specifications.

1. GMP and Regulatory Compliance

- Ensure compliance with cGMP, WHO-GMP, Schedule M, and applicable regulatory requirements.

- Maintain proper documentation as per ALCOA+ principles.

- Ensure implementation of SOPs and work instructions.

- Ensure line clearance before starting each manufacturing activity.

- Ensure proper area, equipment, and personnel status labeling.

- Participate in internal, external, and regulatory audits.

- Ensure timely closure of audit observations and CAPA.

1. Quality Assurance and Quality Control Coordination

- Coordinate with QA and QC departments for smooth production operations.





- Ensure sampling and testing at defined manufacturing stages.

- Monitor in-process quality parameters such as:

- Tablet weight variation.

- Hardness.

- Thickness.

- Friability.

- Disintegration.

- Dissolution, where applicable.

- Capsule fill weight.

- Moisture content.

- Ensure timely investigation of deviations, incidents, and non-conformances.

- Implement corrective and preventive actions (CAPA).

- Ensure products are manufactured as per approved specifications.

1. Manpower Management

- Supervise production officers, supervisors, technicians, and operators.

- Allocate duties and responsibilities to production personnel.

- Prepare shift schedules and manpower requirements.

- Conduct training on GMP, SOPs, safety, and manufacturing procedures.

- Evaluate employee performance and productivity.

- Maintain discipline and improve team performance.

1. Equipment and Maintenance Management

- Ensure availability and proper functioning of manufacturing equipment.

- Coordinate with the engineering department for preventive and breakdown maintenance.

- Ensure equipment cleaning and status labeling.

- Monitor equipment qualification and calibration status.

- Ensure equipment is operated according to approved SOPs.

- Reduce machine breakdowns and manufacturing downtime.

1. Documentation and Batch Record Management





- Review and ensure proper completion of:

- Batch Manufacturing Records (BMR).

- Batch Packing Records (BPR), where applicable.

- Equipment cleaning records.

- Logbooks.

- Area cleaning records.

- In-process control records.

- Yield and reconciliation records.

- Ensure timely documentation and batch record submission to QA.

- Ensure correction of documentation errors according to GDP requirements.

1. Safety and Housekeeping

- Ensure proper implementation of EHS requirements.

- Ensure personnel use appropriate PPE.

- Maintain cleanliness and hygiene in manufacturing areas.

- Ensure proper handling of dust-generating materials.

- Monitor waste disposal and material handling practices.

- Prevent cross-contamination and mix-ups.

1. Productivity and Cost Control

- Monitor production yield and minimize material wastage.

- Improve machine utilization and manpower efficiency.

- Reduce rejection, reprocessing, and production losses.

- Monitor batch cycle time and equipment efficiency.

- Implement continuous improvement initiatives.

- Identify opportunities for process optimization.

1. Validation and Continuous Improvement

- Participate in process validation and cleaning validation activities.

- Support equipment qualification activities.

- Participate in technology transfer and recent product introduction.

- Review process performance and identify improvement opportunities.

- Implement risk assessment and change control requirements.

- Support investigation of out-of-trend and recurring process issues.

Pay: From ₹80,000.00 per month

Work Location: Remote

📌 Manager Production (Amb)
🏢 Alencure Biotech Pvt.LTD
📍 Amb