• 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.
