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
Role & responsibilities To ensure GMP practices are followed during various stages of production activities of finished drug product. To perform in process checks in Tablets/Capsule/Ointment/ Liquid/Dry powder To ensure various operations are complying as per SOP. Daily & Monthly calibration of IPQC instruments. Sampling of Control and Stability samples. To ensure that the facility is maintained in a clean and sanitary conditions. In-process checks during dispensing & secondary packing activities. To ensure timely sampling of finished products, control samples, validation samples & stability samples. To monitor Dispensing of raw material and packing material required for the manufacturing of finished product. Handling of training record logs and training cards. Handling of incident reporting logs and records. Monitoring of environmental conditions during manufacturing operations. Review of filled in BMR/BPR. Any other work assigned by superiors.. Preferred candidate profile Pharmaceutical formulations OSD experience required Stability Must WHO GMP Perks and benefits Free Transportation from Vadodara to Savli (Factory) Free Accident Insurance Free Term Insurance Canteen facility
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