Job Overview
- Responsible for the validation protocol/report preparation.
- Responsible for follow up of Validation.
- Responsible for the study protocols and reports.
- Responsible for review the deviation and monitor the deviation in track-wise.
- Responsibility for preparation and support in cleaning matrix/protocols/reports.
- Responsible for follow up of deviation from plants for conferring the root cause of deviation.
- Responsible for preparation of investigation report.
- Responsible for reviewing the investigation report by QA person.
- Responsible for closer of investigation in track-wise on time.
- Preparation of manufacturing process batch card through the R&D/Pilot report.
- Preparation of different type of cleaning batch cards e.g. Product change over cleaning, periodic cleaning, general cleaning etc.
- Initiation of change controls in Track wise for manufacturing process/product change over cleaning batch cards.
- Responsible for upload of manufacturing/Cleaning batch cards in Smart Team.
- Responsible for follow up of batch cards and cleaning batch cards.
- Responsible for Initiation of CAPA against investigation.
- Responsible for follow up of CAPA.
- Responsible for review the CAPA documents for closer.
- Responsible for CAPA closer in track-wise on time.
- Responsible for review of CAPA and deviation of dispatch for on time closing.
- Responsible for coordinate with plants for query related to track-wise in deviation and CAPA.
- Responsible for coordinate with dispatch person for smooth dispatch.
- Responsible for coordinate with batch card preparation team for CAPA implementation in batch card.
- Responsible for coordinate with engineering department team for CAPA implementation related to equipment's.
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