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