- Review of all quality systems i.e Change controls, Deviations, Market complaints, OOT, OOS, CAPA etc.,
- To monitor Batch manufacturing at CMOs and review and compliance of the documents as per the requirements.
- To conduct/participate internal quality audits & regulatory / customer audits.
- Communications with External Vendors/customers for relevant information/documents
- Co-ordination with cross-functional teams for meeting schedule timelines for commercial and development activities.
- Review of development and commercial batch documents