Production Team Member -
1. Adhere to the company policies and safety norms.
2. Adhere to the SOPs and other laid down procedures in production (Injectable area) of Block- A.
3. To follow general and critical area entry & exit procedures as per respective SOP?s.
4. Preparation of the cleaning / disinfectant solution as per the schedule and respective SOP?s.
5. To perform online entries in GMP documents like BMR?s , BPR?s , log-books etc.. , as per Good Documentation Practice.
6. To ensure line clearance before any related activities & make necessary entries in related in E-BMR
7. To perform area/equipment Cleaning and sanitization activities as per respective SOP?s.
8. To perform area fumigation activities as per the schedule and respective SOP?s.
9. To coordinate with the superiors and other related departments for the smooth functioning.
10. To maintain good personal hygiene and follow the personnel hygiene practices consistently.
11. To follow the good aseptic techniques in the critical area so as to assure the sterility of the product.
12. To perform decartoning (Empty vial inspection) activity as per Production planning.
13. To do Operation & changeover of machines , their trouble shooting?s etc. as per respective SOP?s and instructions of superiors.
14. To ensure the up keep of the equipment , area and GMP records.
15. To participate in media fill as per the schedule.
16. To ensure that all documents are updated/revised periodically to meet cGMP standards.
17. To ensure timely completion of calibrations & preventive maintenance of equipment?s as Per schedule.
18. To undergo training as per the matrix.
19. To do environmental monitoring of area as per respective SOP?s.
20. Inform to superiors in case of any deviations/incident etc.
21. To participate in inspection activities (External/Internal) as per instructions of superiors.
22. To raise the breakdown requests in SAP and inform to all concerned person.
23. To perform reconciliation of the product as per respective SOP/BMR. To ensure that yield of the product at respective stage of Batch Processing is within the Specified Limits.
24. To participate in Dispensing of Materials from Warehouse/Stores.
25. Responsible for all activities like related to Batch manufacturing and filtration of the product and responsible to handle and operate all equipment?s and accessories related to Component preparation and Filter integrity testing , steam sterilization , SIP related documentation for the same activity.
26. Responsible for smooth operation in vial wash & tunnel sterilizer area and Operation of Offline Non-Viable Particle Counter.
27. Responsible for filling activities like glove integrity , VHP (Vaporized Hydrogen Peroxide)
28. Gas Generator , Isolators , Online NVPC (Non-Viable Particle Counter) , Filling Machine , Sealing , ALUS and EDM (External Decontamination Machine).
29. To perform any other task/Project assigned by Production Head. 2.0 Delegation of activities: In absence of role holder , Team member (only designation) shall perform the role. Required Skills
Company Policies, Production, Injectable, GMP, Documentation, Related Activities, Personal Hygiene, Aseptic, Inspection, Production Planning, CGMP, Preventive Maintenance, Environmental Monitoring, SAP, Reconciliation, SOP, Batch Processing, Responsible, Manufacturing, Filtration, Testing, Sterilization, Isolators, Decontamination, Delegation