Career Opportunities: Engineer (19565)

Job Role: Filling & Formulation Associate

The Filling & Formulation Associate is responsible for planning day to day shift activities in coordination with the superior to carry out production activity in order to achieve production targets. They must 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. The associate ensures all team members strictly comply with cGMP procedures and immediately calls attention and corrects any member deviating procedures. They are responsible for recording and maintaining daily reports, reporting any kind of illness or any abnormal health condition to immediate supervisors so that appropriate action can be taken, and adhering to safety, health, hygiene, and environmental measures.

The Filling & Formulation Associate follows dedicated procedures to enter the Drug Product building and Cleanroom area of the Drug Product building as per BM/PDP/SOP/001 and BM/PDP/SOP/004, respectively. They follow dedicated behavior and hygiene as required in the cleanroom area as per procedures (BM/PDP/SOP/146). They strictly implement line clearance procedure as per BM/QA/SOP/026 and do not start line unless it is cleared to operate. They escalate any issue immediately to the superior. The associate carries out and ensures the following activities are performed as per SOP below: monitoring of cleaning activities with correct disinfectant and frequency (BM/PDP/SOP/023), monitoring and recording area differential pressure, temperature and relative humidity (BM/PDP/SOP/018), ensuring housekeeping activity in the cleanroom takes place as per frequency as per BM/PDP/SOP/014, performing fumigation activities as per schedule/frequency (BM/PDP/SOP/005), ensuring wrapping of autoclavable items as per (BM/PDP/SOP/080), ensuring correct handling of autoclavable items (BM/PDP/SOP/047), ensuring dispensed materials are properly transferred to the respective area in the cleanroom (BM/PDP/SOP/075), ensuring sampling are done as per procedures (BM/PDP/SOP/132 and BM/PDP/SOP/135), and strictly implementing status labeling (BM/PDP/SOP/121). They carry out and ensure the following operation activities are performed as per EOP below: monitoring and recording LAF reading as per defined frequency (BM/PDP/EOP/002), monitoring and recording usage, UV hour reading and cleaning of passbox (BM/PDP/EOP/004 and BM/PDP/EOP/005), performing filter integrity operation and cleaning as per procedures (BM/PDP/EOP/012), performing operation and cleaning of peristaltic pump as per procedures (BM/PDP/EOP/016), performing operation of fogging machine as per procedures (BM/PDP/EOP/019), performing operation and cleaning of ultrasonic bath as per procedures (BM/PDP/EOP/054), and performing operation and cleaning of the autoclave as per (BM/PDP/EOP/006). The associate complies with any other general SOPs and EOPs that relate to production activities in PDP and performs aseptic connection, aseptic assembling and disassembling of filling machine parts.

The Filling & Formulation Associate is responsible for documentation specifically on preparation, review and revision of BMR, SOP's, EOP's, ECC's. They are responsible for online documentation of logbook and checklist, online updating of BMR with respect to filling activities, ensuring the correctness and accuracy of the data to all the batch records, status labels, checklist, logbooks and other documents related to manufacturing activities, filling in the required data in batch record online with correct GDP, ensuring completeness of batch record before submitted to QA, updating and ensuring the updation of the status board, directly involved during qualification and validation of equipment and process, ensuring preventive maintenance and calibration of equipment and instrument to be within due date in coordination with EM and IA, instructing and ensuring all team members in the proper use of required PPEs, complying with audit observations with respect to manufacturing activities, and adhering to the shift schedule or reporting for any change in schedule.

Required Education Qualification: BACHELORS ENGINEERING Required Experience: 5 - 20 years