Drug Product, MFG Autoclaving Vial Washing F
Salary undisclosed
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- 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 superior 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 behavior and hygiene as required in cleanroom area as per procedures (BM/PDP/SOP/146).
- Ensures all team members are properly trained before assigning tasks (BM/PDP/SOP/105).
- 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:
- To carry out and ensure that the following operation activities are performed as per Equipment Operating Procedures below:
- Comply in any other general SOPs and EOPs that related to production activities in PDP.
- Responsible for documentation specifically on preparation, review and revision of BMR, SOP’s, EOP’s, ECC’s.
- Online documentation of logbook and checklist.
- Ensure the correctness and accuracy of the data to all the batch records, status labels, checklist, logbooks and other document related to manufacturing activities.
- Responsible to fill in the required data in batch record online with correct GDP.
- Ensure completeness of batch record before submitted to QA.
- Directly involved during qualification and validation of equipment and process
- To ensure Preventive Maintenance and Calibration of Equipment and Instrument to be within due date in coordination with EM and IA.
- Instructs and ensures all team members in the proper use of required PPEs.
- To comply with audit observations with respect to manufacturing activities.
- Responsible for manpower management by allocating defined responsibilities to the team members.
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