- Batch initiation of routine batches as per production planning.
- To carry out the Cleaning, Operation, documentation and maintenance of all the vial washing tunnel area equipment.
- Responsible for online documentation as per cGMP along with routine logbook management of production activity and equipment.
- Responsible for entire filling activity to be carried out as per compliance and process requirement.
- To ensure the entire vial washing depyrogenation activity to be carried out as per compliance and process requirement.
- Responsible for preparation of departmental related documents (SOP/BMR/Protocols)
- Process data compilation of the filling, vial washing depyrogenation tunnel area.
- Execution of various (Internal External) equipment /process related validation activities
- To ensure the effective cleaning and sanitation of the Core area, vial washing and depyrogenation tunnel area as per schedule.
- Preparation and updating of routine production documents.
- Ensure production and process related maintenance schedule
- Responsible to carry out media fill activity as per schedule.
- SAP entry of batch related information.
- To ensure GMP compliance as per the applicable National and International rules and guidelines Such as World Health Organization (WHO).
- Coordination with warehouse for material issuances and carry forward to material preparation area.
- Coordination with QC for QC related activity.
- Coordination with QA for daily operational issues.
- Coordination with Engineering for daily operational issues.
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