Summary

We are looking for a responsible for executing pharmaceutical manufacturing operations in compliance with cGMP, regulatory guidelines, and approved Batch Manufacturing Records (BMRs). The role ensures efficient production, proper documentation, adherence to quality standards, and coordination with QA, QC, and Engineering teams to deliver safe and high-quality products. The position also supports deviation handling, process improvement, and maintaining a safe manufacturing environment.

Key Responsibilities

• Implementation of cGMP at all stages of Production
• Initiation of quality system documents like change control, deviation, CAPA and incident report
• To ensure the safety of product and personal working
• Review of production documents like BMR’s and SOPs
• To carry out the duties assigned by superior’s time to time
• Maintaining of discipline in the work area and manpower
• Ensure the Cleanness of the equipment and its accessories to the line clearance
• To carry out the line clearance activities as per the line clearance SOP
• Ensure the calibration status of balance prior to usage
• To carryout production activities as per the respective approved BMR, accordingly update the BMR logbooks
• To ensure the labels and batch details are properly affixed on the container and packing materials to avoid misuse or mix up
• To coordinate with maintenance department to carryout preventive maintenance in the department
• To identify and initiate training for workers to carryout activities effectively
• To monitor control and handling of change parts of machines
• To execute the production activity (Granulation) smoothly and meet production schedule as per plan
• Ensure the production operation, cleaning and material movement activities performed by operators/helpers correctly and accordingly document the same in relevant batch documents and logs
• In absence of me my reporting officer will take responsibility

Skills Required

• Attention to detail
• Compliance mindset
• Problem-solving ability
• Teamwork and communication
• Time management