Purpose
To handle the shop floor activities shift wise by supervising the Compression section and coordinating manufacturing activities during the assigned shift to ensure production targets are achieved in compliance with cGMP, SOPs, and quality standards.
Position / Job Title
Senior Officer
Department
Manufacturing – Production
Reporting To
Assistant Manager
Location
Ambernath
Years Of Experience
5-6 Years
Dosage Form
Solid Orals
Job Responsibilities / Deliverables
To monitor & control the manufacturing process of each optimization / validation / commercial batch & to provide technical inputs as & when required. Identity the possible bottlenecks & area of improvements in the process.
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.
Preparation & Execution of SOP across all areas in manufacturing departments.
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.
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. Compression section.
Basic knowledge of QMS/documentation (Change control, Deviation, Investigation) cGMP, GDP, Executed-BMR review etc.
Basic SAP Knowledge related to production activity.
Additional Notes
Role is expected to work in all shifts.
