MANAGER

Department Details

Role Summary

Manager- Injectable Production lead

Key Responsibilities

• Handling of filling lines with isolator - Vial, Prefilled syringe & Cartridge including visual inspection and packing lines • Handling of Lyophilizer with Automatic loading and unloading system • Handling of Compounding, filtration, filling and packing activities • Handling of Aseptic operation and training requirement of employees • To handle injectable regulatory audits and to keep the facility all time readiness. • To handle end to end Qualification of all the equipment's, facility, media fills and Batches execution. • To handle Pen devices - assembling and packing • To setup the injectable facility w.r.t Equipment's, instruments, process meeting the product and regulatory requirement, • Ensure procurement of all the material required for Equipment and area qualificaiton on time for start-up till execution of media fills and batches and also routine qualifications • To handle Quality& operational Tools - DMS, Track wise, VLMS, MES - paperless system • Coordination with Cross functional team for executing the qualification and production activities. • Responsible for Preparation & Review of URS, Risk assessments, technical rationale documents for all the Equipment's and instruments - injectable facility. • To prepare, review and approve Process and Packaging Validation protocol or report • To initiate and work upon Operational Excellence projects. • To ensure the compliances of the documents and practices. • Indenting support and procurement in SAP coordination for the operations. • Coordinate for the New project's completion as per the scheduled timelines • Preparation, review and approval of SOPs, Protocols, batch records and QMS documents like change controls, CAPA, deviations and other quality documents, whenever required as per GDP. • Adherence to safety, Health and Environment norms for this project. • Ensuring the set targets of Production and deliveries as per norms of quality, cost, and efficiency. • Manage and optimize the production processes for injectables ensuring efficiency and compliance with quality standards. • Preparation of opex and capex requirements • Ensure the qualificaiton of area and equipment's in all time readiness with compliance state. • Address and resolve any issues or challenges that arise during production process promptly and effectively. • Faster effective communication both within the team and with other departments to ensure smooth operations and coordination

Educational Qualifications

Required Education Qualification: B.Pharma
Required Experience: 13 - 16 years