Title:  Senior Officer

Qualification : B.Pharma or M.Pharma

Experience : 4.5 to 6 Years

GMP documents as per following but not restricted to Equipment sequential log, Temperature and %RH record, Daily, weekly and Monthly cleaning records of Manufacturing area, Balance calibration, In process and under test approval label, Tool set cleaning record, Tool set utilization record etc.

Batch manufacturing Records. In process and Finished Product Test Requisitions.

Bulk quarantine / Staging room In-out record.

2.             The Officer is responsible for overall production activities of the Tablet department (FBE section) on day to day basis in achieving total production requirements in quantity, quality and GMP compliance in department and Execution of production activity. To assist other Officer in manufacturing and controlling the functions related to Tablet department.

3.             To assist establishing a system in accordance with Good Manufacturing Practice guidelines and Responsible for follow established / new procedures, maintaining and updating existing procedures in the department.

4.             Responsible to co-maintain, coordinate for validation and GMP in all departments along with the Quality Assurance officer and to coordinate with Quality control department in matters relating to

product quality.

5.             Responsible for Good Manufacturing Practice/training to staffs and operator in the all department.

6.             Responsible for optimization of the resources namely men, material and machine in respective department.

7.             Make daily reports on day to day activities concerning the department.

8.             Responsible for Calibration, qualification and validation activity of respective equipments or products.

9.             Indenting and procurement of machineries, change parts, spares and material required in respective department.

10.           Destruction note preparation and execution.

11.           Maintaining the GMP documents like equipment logbooks, records of physical monitoring and housekeeping records.

12.           Training the subordinates and manpower to meet the organizational goals and achieve GMP compliance.

13.           Help the subordinates into standardize production activities to achieve better efficiency and product quality.

14.           The Officer will handle the responsibility of Officer in his absence.

15.           Coordinate with related departments like with Warehouse & MIS for the materials to achieve schedule plan, with the Engineering department for preventive maintenance schedule.

16.           BMR/ SOP/ Protocol preparation for the new product/New machines. Revision of BMR / SOP /

Protocol whenever required and execution of BMR/ SOP/ Protocol.