Associate

Responsibilities:
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
c) (BM/PDP/EOP/004 and BM/PDP/EOP/005).
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
f) (BM/PDP/EOP/016).
g) Performing operation of micro mist fogging machine as per procedures
(BM/PDP/EOP/019).
h) Performing operation and cleaning of ultrasonic bath as per procedures
i) (BM/PDP/EOP/054).
j) 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.
16. Online documentation of logbook and checklist.
17. Online updating of BMR with respect to Filling activities.
18. Ensure the correctness and accuracy of the data to all the batch records, status
labels, checklist, logbooks and other document related to manufacturing activities.
19. Responsible to fill in the required data in batch record online with correct GDP.
20. Ensure completeness of batch record before submitted to QA.
21. Updating and ensuring the updation of the status board.
22. Directly involved during qualification and validation of equipment and process

Responsibilities:
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
c) (BM/PDP/EOP/004 and BM/PDP/EOP/005).
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
f) (BM/PDP/EOP/016).
g) Performing operation of micro mist fogging machine as per procedures
(BM/PDP/EOP/019).
h) Performing operation and cleaning of ultrasonic bath as per procedures
i) (BM/PDP/EOP/054).
j) 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.
16. Online documentation of logbook and checklist.
17. Online updating of BMR with respect to Filling activities.
18. Ensure the correctness and accuracy of the data to all the batch records, status
labels, checklist, logbooks and other document related to manufacturing activities.
19. Responsible to fill in the required data in batch record online with correct GDP.
20. Ensure completeness of batch record before submitted to QA.
21. Updating and ensuring the updation of the status board.
22. Directly involved during qualification and validation of equipment and process

Required Education Qualification: B.Sc

Required Experience: 2 - 4 years