Dossier preparation as per CTD/ACTD/eCTD/Regional guidelines. To co-ordinate with plant team i.e. QA, QC, Production department for availability of technical & legal documents in the given time-line. Review of documents received from plant team and co-ordinate with respective departments in case of any discrepancies. Review of dossiers prepared by team-mates. To ensure that the registration samples be available as per pre-defined time-frame. Submission of response to Queries / Deficiencies raised by Customers / Regulatory Authorities within timeline. Artworks review & approval Co-ordination with Clients / Customers for the registration updates, plant approval process etc. To maintain & update the records for all submissions & regulatory related activities
Role & responsibilities 1. Accurately punching the sale order into the system. 2. Generating the requirements for the respective order. 3. Co-coordinating with the purchase team to the release the order and requirements timely. 4. Look after the Batch creation of the products to be taken into production.. 5. Prepare Proforma Invoices for respective orders. 6. Coordinating with the customers to obtain the Inspection approvals prior to the shipment. 7. Analyzing the production plan to ensure with the order requirements. 8. Communicating with each department to facilitate smooth order processing 9. Provide support and assistance to other departments as needed to maintain overall Operational efficiency. Preferred candidate profile Pharmaceutical formulation
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