Purpose

To handle the shop floor activities shift wise by supervising the Coating section along with document review activity and coordinate with manufacturing and cross-functional departments to ensure compliance during the assigned shift, while achieving production targets in alignment with cGMP, SOPs, and quality standards.

Position / Job Title

Officer

Department

Manufacturing - Production

Reporting To

Assistant Manager

Location

Ambernath

Years Of Experience

2 Years

Dosage Form

Solid Orals

Job Responsibilities / Deliverables

Operation Efficiency

Possess adequate foundational knowledge of key unit operations like sifting, granulation, compression, coating, and imprinting—along with an understanding of their basic principles.

To monitor & control the manufacturing process of each optimization / validation / commercial batch & to provide technical inputs as & when required. Identify the possible bottlenecks & area of improvements in the document.

To get adhere to the production plan to achieve the targeted output with maximum capacity utilization.

To ensure the online documentation of production activities adhering to cGMP norms.

Process Standardization

Execute and control process to ensure consistency in unit operations, thereby reducing errors and deviations.

Capacity utilization of manufacturing department & achieve minimum cycle time for dispatch of goods.

To do the troubleshooting activities wherever required.

To maintain the BCT of the product.

Coordination & Cross-Functional Support

To co-ordinate Manufacturing, QA, QC, Warehouse and Engineering to ensure smooth and timely execution of documents and process activities.

Co-ordinate with QA and cross functional team and making documents available on the shop floor for the execution of batches.

Ensuring the minimum breakdowns of the equipment by participating in the preventive maintenance and calibration activity.

QMS Activities

To participate in change control, deviation, investigation wherever required.

To participate in the investigation of Market complaints or product recalls on account of manufacturing deficiencies.

Qualifications & Pre-Requisites

B. Pharm

Knowledge of unit operations involved in manufacturing of solid oral dosage forms i.e. Coating section

Basic knowledge of QMS/documentation (Change control, Deviation, Investigation) cGMP, GDP.

Basic SAP Knowledge related to production activity.

Additional Notes

Role is expected to work in all shifts.

Officer/Sr. Officer - Quality Control

Officer