Job Description

• Department : Drug Product
  
• Sub-Department : Filling
  
• Job Responsibilities:
  
• Primary –
  
• 1. To plan day to day shift activities in coordination with the superior to carry out production activity in order to achieve production targets.
  
• 2. To ensure that all production activities are carried out in compliance with the cGMP requirements by strictly adhering to the standard operating procedures and good documentation practices.
  
• 3. Ensures all team members strictly comply with cGMP procedures and immediately calls attention and corrects any member deviating procedures.
  
• 4. To record and maintain daily reports.
  
• 5. Responsible for reporting any kind of illness or any abnormal health condition to immediate superior so that appropriate action can be taken (BM/PDP/SOP/115).
  
• 6. Adherence to safety, health, hygiene and environmental measures.
  
• 7. Follow dedicated procedures to enter Drug Product building as per BM/PDP/SOP/001.
  
• 8. Follow dedicated procedures to enter the Cleanroom area of Drug Product building as per BM/PDP/SOP/004.
  
• 9. Follow dedicated behaviour and hygiene as required in the cleanroom area as per procedures (BM/PDP/SOP/146).
  
• 10. Ensures all team members are properly trained before assigning tasks (BM/PDP/SOP/105).
  
• 11. Strictly implements line clearance procedure as per BM/QA/SOP/026. Does not start a line unless it is cleared to operate. Escalates any issue immediately to superior.
  
• 12. To carry out and ensure that the following activities are performed as per Standard Operating Procedures below:
  
• a) Monitoring of cleaning activities with correct disinfectant and frequency (BM/PDP/SOP/023).
  
• b) Monitoring and recording area differential pressure, temperature and relative humidity (BM/PDP/SOP/018).
  
• c) Ensure housekeeping activity in cleanroom take place as per frequency as per BM/PDP/SOP/014
  
• d) Performing fumigation activities as per schedule / frequency (BM/PDP/SOP/005).
  
• e) Ensure aseptic connection and aseptic assembling of machine parts as per (BM/PDP/SOP/140).
  
• f) Ensure handling routine and non-routine intervention as per procedures (BM/PDP/SOP/139).
  
• g) Ensure filtration of the formulated solution for Filling are performed as per (BM/PDP/SOP/082 and BM/PDP/SOP/093).
  
• h) Ensure cleaning after filling to be done as per procedures (BM/PDP/SOP/114).
  
• i) Ensure CIP and SIP OF Mobile Vessels are perform as per (BM/PDP/SOP/040).
  
• j) Ensure Automation Formulation System of Formulation Vessel, Filtration Skids and Transfer Vessel are perform as per (BM/PDP/SOP/117).
  
• k) Ensure cleanliness and sterilization of Formulation Vessel and Transfer Vessel (BM/PDP/SOP/071).
  
• l) Preparation of solution according to the different batches and the production plan for vials / cartridges.
  
• m) To ensure wrapping of autoclavable items as per (BM/PDP/SOP/080)
  
• n) To ensure correct handling of autoclavable items (BM/PDP/SOP/047).
  
• o) Perform testing for glove port and ensure glove port cleanliness (BM/PDP/SOP/069 and BM/PDP/SOP/152).
  
• p) Ensure sampling is done as per procedures (BM/PDP/SOP/145).
  
• q) Strictly implements status labelling (BM/PDP/SOP/121).
  
• r) Ensure Primary Packing Materials are destroyed as per procedures (BM/PDP/SOP/099).
  
• 13. To carry out and ensure that the following operation activities are performed as per Equipment Operating Procedures below:
  
• a) Monitoring and recording LAF reading as per defined frequency (BM/PDP/EOP/002).
  
• b) Monitoring and recording usage, UV hour reading and cleaning of passbox (BM/PDP/EOP/004 and BM/PDP/EOP/005).
  
• c) Performing operation and cleaning of pH meter as per procedures (BM/PDP/EOP/010).
  
• d) Performing filter integrity operation and cleaning as per procedures (BM/PDP/EOP/012.
  
• e) Performing operation and cleaning of peristaltic pump as per procedures (BM/PDP/EOP/016).
  
• f) Performing operation, cleaning and daily verification of weighing balances as per procedures (BM/PDP/EOP/037).
  
• g) Performing operation of a micro mist fogging machine as per procedures (BM/PDP/EOP/019).
  
• h) Performing operation and cleaning of ultrasonic bath as per procedures (BM/PDP/EOP/054).
  
• i) Performing operation of Pharma-X Heat Exchanger as per procedures (BM/PDP/EOP/061).
  
• 14. Comply in any other general SOPs and EOPs that related to production activities in PDP.
  
• 15. Responsible for documentation specifically on preparation, review and revision of BMR, SOP’s, EOP’s, ECC’s.
  
• 16. Online documentation of logbook and checklist.
  
• 17. Ensure the correctness and accuracy of the data to all the batch records, status labels, checklist, logbooks and other document related to manufacturing activities.
  
• 18. Responsible for filling in the required data in batch record online with correct GDP.
  
• 19. Ensure completeness of the batch record before submitted to QA.
  
• 20. Directly involved during qualification and validation of equipment and process
  
• 21. To ensure Preventive Maintenance and Calibration of Equipment and Instrument to be within due date in coordination with EM and IA.
  
• 22. Instructs and ensures all team members in the proper use of required PPEs.
  
• 23. To comply with audit observations with respect to manufacturing activities.
  
• 24. Responsible for manpower management by allocating defined responsibilities to the team members.