ASSOCIATE

Department Details

Role Summary

• To plan day to day shift activities in coordination with the superior to carry out production activity in order to achieve production targets. • 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. • Ensures all team members strictly comply with cGMP procedures and immediately calls attention and corrects any member deviating procedures. • To record and maintain daily reports. • 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). • Adherence to safety, health, hygiene and environmental measures. • Follow dedicated procedures to enter Drug Product building as per BM/PDP/SOP/001. • Follow dedicated procedures to enter Cleanroom area of Drug Product building as per BM/PDP/SOP/004. • Follow dedicated behaviour and hygiene as required in cleanroom area as per procedures (BM/PDP/SOP/146). • 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. • 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). • 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). • Comply in any other general SOPs and EOPs that related to production activities in PDP. • Performing aseptic connection, aseptic assembling and dissembling of filling machine parts

Key Responsibilities

• To plan day to day shift activities in coordination with the superior to carry out production activity in order to achieve production targets. • 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. • Ensures all team members strictly comply with cGMP procedures and immediately calls attention and corrects any member deviating procedures. • To record and maintain daily reports. • 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). • Adherence to safety, health, hygiene and environmental measures. • Follow dedicated procedures to enter Drug Product building as per BM/PDP/SOP/001. • Follow dedicated procedures to enter Cleanroom area of Drug Product building as per BM/PDP/SOP/004. • Follow dedicated behaviour and hygiene as required in cleanroom area as per procedures (BM/PDP/SOP/146). • 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. • 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). • 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). • Comply in any other general SOPs and EOPs that related to production activities in PDP. • Performing aseptic connection, aseptic assembling and dissembling of filling machine parts

Educational Qualifications

Required Education Qualification: B.Sc
Required Experience: 2 - 4 years