Biocon Biologics Limited Openings for JUNIOR ASSOCIATE/EXECUTIVE/SENIOR ASSOCIATE/JUNIOR ASSOCIATE-India/ Malaysia
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 supervisors 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. 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
11. 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) To ensure wrapping of autoclavable items as per (BM/PDP/SOP/080)
f) To ensure correct handling of autoclavable items (BM/PDP/SOP/047).
g) To carry out Chamber Leak Test and Bowie Dick Test to ensure the autoclaves are functioning properly.
h) Ensure dispensed materials are properly transferred to respective area in cleanroom (BM/PDP/SOP/075).
i) Ensure sampling are done as per procedures (BM/PDP/SOP/132 and BM/PDP/SOP/135).
j) Strictly implements status labelling (BM/PDP/SOP/121).
12. 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 filter integrity operation and cleaning as per procedures (BM/PDP/EOP/012.
d) Performing operation and cleaning of peristaltic pump as per procedures (BM/PDP/EOP/016).
e) Performing operation of micro mist fogging machine as per procedures (BM/PDP/EOP/019).
f) Performing operation and cleaning of ultrasonic bath as per procedures (BM/PDP/EOP/054).
g) To perform operation and cleaning of the Autoclave as per (BM/PDP/EOP/006).
13. Comply in any other general SOPs and EOPs that related to production activities in PDP.
14. Performing aseptic connection, aseptic assembling and dissembling of filling machine parts.
15. Responsible for documentation specifically on preparation, review and revision of BMR, SOP’s, EOP’s, ECC’s.
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 supervisors 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. 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.
11. 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) To ensure wrapping of autoclavable items as per (BM/PDP/SOP/080)
f) To ensure correct handling of autoclavable items (BM/PDP/SOP/047).
g) To carry out Chamber Leak Test and Bowie Dick Test to ensure the autoclaves are functioning properly.
h) Ensure dispensed materials are properly transferred to respective area in cleanroom (BM/PDP/SOP/075).
i) Ensure sampling are done as per procedures (BM/PDP/SOP/132 and BM/PDP/SOP/135).
j) Strictly implements status labelling (BM/PDP/SOP/121).
12. 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 filter integrity operation and cleaning as per procedures (BM/PDP/EOP/012.
d) Performing operation and cleaning of peristaltic pump as per procedures (BM/PDP/EOP/016).
e) Performing operation of micro mist fogging machine as per procedures (BM/PDP/EOP/019).
f) Performing operation and cleaning of ultrasonic bath as per procedures (BM/PDP/EOP/054).
g) To perform operation and cleaning of the Autoclave as per (BM/PDP/EOP/006).
13. Comply in any other general SOPs and EOPs that related to production activities in PDP.
14. Performing aseptic connection, aseptic assembling and dissembling of filling machine parts.
15. Responsible for documentation specifically on preparation, review and revision of BMR, SOP’s, EOP’s, ECC’s.
