About this role
- Logging, review of Market complaints and fulfilments of other market requirements.
- Logging, review of Return Goods and product recall.
- Regulatory Compliances.
- Responsible for customer audit and its responses.
- Review and evaluation of Deviations and CAPA in LIMS.
- Review and evaluation of Out of Specification, NCR etc.
- Review and evaluation of Out of Trend.
- Review and evaluation of Preventive Maintenance in SAP
- Logging and review of Reprocess and Rework.
- Co-ordination with other departments for cGMP compliances.
- Responsible for vendor qualification by vendor audits/their questionnaire and documents.
- Vendor related activities and material management in SAP.
- Preparation & Review of Approved Vendor list.
- Internal Audits.
- Preparation and review of Site Master File (SMF).
- Coordination with local FDA for various FDA related work.
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