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Production Manager

1 month ago

Bengaluru, India Biocon Full time

Job Title: Manager

Department : Production

Nature of Business : Injectable - Pharma Manufacturing

Role : Lead Injectable-Production

Qualification: B Pharm / M Pharm

Experience : 12Yrs to 15 Yrs.


Key Responsibilities

  1. Handling of filling lines with isolator - Vial, Prefilled syringe & Cartridge including visual inspection and packing lines.
  2. Handling of Lyophilizer with Automatic loading and unloading system
  3. Handling of Compounding, filtration, filling and packing activities.
  4. Handling of Aseptic operation and training requirement of employees.
  5. To handle injectable regulatory audits and to keep the facility all time readiness.
  6. To handle end to end Qualification of all the equipment's, facility, media fills and Batches execution.
  7. To handle Pen devices - assembling and packing .
  8. To setup the injectable facility w.r.t Equipment's, instruments, process meeting the product and regulatory requirement.
  9. Ensure procurement of all the material required for production on time for start-up till execution of media fills and batches.
  10. To handle Quality& operational Tools - DMS, Track wise, VLMS, MES - paperless system.
  11. Responsible for Preparation & Review of URS, Risk assessments, technical rationale documents for all the Equipment's and instruments - injectable facility.
  12. To prepare, review and approve Process and Packaging Validation protocol or report. To prepare, review and approve BMR/BPR for different products.
  13. To initiate and work upon Operational Excellence projects.
  14. To ensure the compliances of the documents and practices.
  15. Indenting support and procurement in SAP coordination for the operations.
  16. Coordinate for the New project's completion as per the scheduled timelines
  17. Preparation, review and approve of SOPs, Protocols, batch records and QMS documents like change controls, CAPA, deviations and other quality documents, whenever required as per GDP.
  18. Adherence to safety, Health and Environment norms for this project.
  19. Ensuring the set targets of Production and deliveries as per norms of quality, cost, and efficiency.
  20. Manage and optimize the production processes for injectables ensuring efficiency and compliance with quality standards.
  21. Preparation of opex and capex requirements.
  22. Ensure the operation, cleaning of area and equipment's in all time readiness with compliance state.
  23. Address and resolve any issues or challenges that arise during production process promptly and effectively.
  24. Faster effective communication both within the team and with other departments to ensure smooth operations and coordination.
  25. Efficiently allocate resources, including personnel, equipment and materials to meet production goals.