Team Member – Regional RA

Submit product documents to regulatory authorities in accordance with country specific regulatory requirements to ensure approvals and market launch in stipulated time and handle post-approval changes, maintenance, and updation of documents during the products life-cycle

Accountabilities
I. Achieve timely submission of dossier/DMF and deficiency responses to regulatory authority by reviewing, collating, and compiling documents in order to ensure approvals for launch in stipulated time
II. Submit post approval variations for changes that improves productivity, cost-effectiveness, quality of the product by reviewing, collating, compiling the variation application to meet the delivery within timelines and maintain Product Marketing Authorization, Renewals/Sunset clause to ensure continuous validity of marketing authorisations.
III. Maintain, and update product dossier as required to meet changes in Cipla������s internal systems, changes in regulatory guidelines, and to meet the need of regulatory requirements
IV. Update the database (PRC/SAP-RA/ table) associated with product dossier approvals by including registration details in database.
V. Provide Regulatory support throughout the life cycle of the product for smooth functioning
VI. Provide the informatuitability and availability of dossier for out-licensing and in-licensing
VII. Check with regulatory authorities (EU, NZ & TGA) for submission activity and approval status for submission done

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Junior Officer – Production

Monitor and execute the production activities in an area during the shift by maintaining cGMP and safety norms to achieve production targets
Accountabilities
I. Execute production activities in a shift by managing available resources to achieve production target
II. Maintain standard process parameters as per BMRs and other supporting documents for achieving production target and maintaining quality
III. Prepare manufacturing records and update online documentation to meet production and cGMP requirements
IV. Follow safe work processes and ensure safety appliances are utilised during production activities in shifts to create a safe working environment
V. Execute production activities in a shift by managing available resources to achieve production target

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Junior Operator – Packing

Operate & maintain packing machines to achieve quality product & shift wise targeted output with maximum utilisation
Accountabilities
I. Prepare the machine for packing operation as per production plan by using proper resources to ensure smooth operations
II. Operate the packing machines by using minimum resources to get quality product
III. Execute and update online documentation to meet cGMP requirements and maintain data integrity Fill Machine logs. Document entries/SOP and process simplification to meet cGMP.
IV. Perform packing machine operations safely to avoid safety incidences by appropriately handling the machines and thereby maintaining high standard of safety
V. Deliver training to workmen and adhere cGMP and safety guidelines in production process to ensure smooth operations

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