Each departments have their own responsibilities in Pharmaceutical and based up on the job responsibility every body has to work.
Job responsibility shall be assigned to the persons based upon Educational Qualification and Experience and according to the job responsibility every body has to take Standard Operating Procedure (SOP) Training.
Following are the job responsibilities of Production personnel and this topic will help to the freshers as well as Experience personnel to gain some basic knowledge in Pharmaceuticals.
- To maintained Manufacturing and packing area clean and presentable for audit.
2. Recording of Temperature, Relative Humidity and Differential Pressure in Manufacturing and Packing area.
3. Filling the Equipment and Instrument Logbook in Manufacturing and Packing area.
4. Ensure compliance with current Good manufacturing Practice (cGMP) on shop floor.
5. To follow Good Documentation practices and safety instructions & ensure compliance while working in manufacturing and Packing area.
6. Operating the machines as per product requirements and Manpower handling in Production and Packaging department.
7. Filling of Batch Manufacturing and Batch Packing Record in Manufacturing and packing area.
8. To perform Daily or Monthly weighing Balance calibration or verification in Manufacturing and Packing area.
9. To procure, receive and manage all change parts, Stereos, Sieves, Screens, Finger bags, Punches, Dies etc for Manufacturing and Packing area.
10. Planning and execution of batches to be manufactured in process and Packaging area.
11. To maintain and Fill the documents online and review the documents like Manufacturing and Packing Records.
12. Review of Batch Manufacturing Record (BMR), Batch Packing Record (BPR), Master Formula Record and Master Packing Record.
13. Execution of process equipment qualification by coordinating with qualification team and vendor.
14. Preparation or Review of Failure investigation, Market complaint investigation, Change control, Deviation, Out of Specification and investigation routed through Quality Management System (QMS).
15. To initiate Change Control if required and Fill Deviation form in case of any Non conformance
16. Review protocols and reports for cleaning, Process validation, Mapping, Hold time study and qualifications etc.
17. To ensure for completion of Preventive maintenance as per schedule.
18. Responsible for compliance for all types of regulatory audits , Inspection and/ or internal quality audit
19. Preparation of Job responsibility for Production and Packaging personnel.
20. Preparation of Standard Operating Procedure in Manufacturing and Packing Area.
21. To Provide SOP Training to the sub-ordinates and newly joined personnel.
22. Section wise allocation of work to sub-ordinates.
23. Ensure implementation of Pest control program at site.
24. Control of Plant Hygiene and manufacturing environment and environmental monitoring in area .
25. To ensure the completion of Monthly Training for Production and Packaging personnel.
26. SAP and ERP Transaction related to Manufacturing and Packaging department.
27. To implementation of Corrective and Preventive Action at shop floor.
28. To guide or Explain the Auditors and External persons about the manufacturing and Packing area if required.
29. To coordinate with other departments like Engineering, Quality assurance, Warehouse and Quality Control for smooth running of manufacturing and Packing activities.
Copy the above contents may be subject to copy writing and not allowed
Refer responsibilities of Quality Assurance : https://pharmaceuticalupdates.com/2019/01/26/responsibility-of-quality-assurance-personnel-or-quality-unit-in-pharmaceuticals/
3 thoughts on “Production Personnel Responsibilities in Pharmaceuticals”
excellent and easy understanding.