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 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 :

Required Experience : 13 - 16 years