Job Description

Department DetailsRole Summary1. 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 Cleanroom area of Drug Product building as per BM/PDP/SOP/004.
9. Follow dedicated behaviour and hygiene as required in 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 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 perform 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 Vessel 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 are done as per procedures (BM/PDP/SOP/145).
q) Strictly implements status labelling (BM/PDP/SOP/121).
r) Ensure Primary Packing Materials destructed 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).Key Responsibilities1. 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 Cleanroom area of Drug Product building as per BM/PDP/SOP/004.
9. Follow dedicated behaviour and hygiene as required in 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 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 perform 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 Vessel 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 are done as per procedures (BM/PDP/SOP/145).
q) Strictly implements status labelling (BM/PDP/SOP/121).
r) Ensure Primary Packing Materials destructed 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).Educational QualificationsRequired Education Qualification:
Required Experience: - years

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