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SENIOR DIRECTOR

SENIOR DIRECTOR

Biocon Biologics Limitedindia, India
1 day ago
Job description

Department Details

Role Summary

  • Roles & Responsibilities
  • Responsible for ensuring equipment & plant reliability to support production schedules, building team capability to minimize dependency on OEM's (Original Equipment Manufacturers), and leading the Maintenance Efficiency Program and engineering excellence.
  • Role involves leading the engineering team of Drug Product blocks and utilities.
  • Having good hands-on experience of high speed vial / cartridge and PFS filling line with RABs / Isolator systems.
  • Have worked on Devices and Packing lines.
  • Leading the engineering function during all regulatory audits, ensuring all time audit readiness
  • Responsibilities include leading safety standards & behavior in engineering & across, collaborating with cross functional teams for seamless support, and ensuring implementation of & adherence to QMS (Quality Management System).
  • Responsible for the overall routine and non- routine maintenance of plant and equipment
  • Responsible for the implementation of continuous improvement projects, and ensuring adherence to defined standards and procedures
  • Ensure annual service contracts for upkeep and troubleshoot of process equipment and utilities, inclusive of plant and facility maintenance.
  • Responsible for budget and financial control for operating expenses of process, facility utilities and energy budgets.
  • Coordinate with statutory, regulatory and government agencies for compliance with applicable acts
  • Implement energy conservation measures and water management procedures, ensure adherence to PMP (Preventive Maintenance Program) / Validation & calibration schedule, and review engineering SOP (Standard Operating Procedures) and other relevant documents along with QA (Quality Assurance).
  • Review team member's activities / schedules for compliance (for review of preventive maintenance, calibration, building maintenance schedules)
  • Impart periodic GMP (Good Manufacturing Practices) refresher trainings to team along with recruitment, retention, supervision and motivation of personnel.
  • Responsible for monitoring of spares, ensuring availability of adequate spares, consumables and resources, and implement maintenance management system through SAP system.
  • Ensure 100% safety compliance and follow continuous improvement programs and by supporting safety and other functions to avoid any safety incidents

Key Responsibilities

  • Roles & Responsibilities
  • Responsible for ensuring equipment & plant reliability to support production schedules, building team capability to minimize dependency on OEM's (Original Equipment Manufacturers), and leading the Maintenance Efficiency Program and engineering excellence.
  • Role involves leading the engineering team of Drug Product blocks and utilities.
  • Having good hands-on experience of high speed vial / cartridge and PFS filling line with RABs / Isolator systems.
  • Have worked on Devices and Packing lines.
  • Leading the engineering function during all regulatory audits, ensuring all time audit readiness
  • Responsibilities include leading safety standards & behavior in engineering & across, collaborating with cross functional teams for seamless support, and ensuring implementation of & adherence to QMS (Quality Management System).
  • Responsible for the overall routine and non- routine maintenance of plant and equipment
  • Responsible for the implementation of continuous improvement projects, and ensuring adherence to defined standards and procedures
  • Ensure annual service contracts for upkeep and troubleshoot of process equipment and utilities, inclusive of plant and facility maintenance.
  • Responsible for budget and financial control for operating expenses of process, facility utilities and energy budgets.
  • Coordinate with statutory, regulatory and government agencies for compliance with applicable acts
  • Implement energy conservation measures and water management procedures, ensure adherence to PMP (Preventive Maintenance Program) / Validation & calibration schedule, and review engineering SOP (Standard Operating Procedures) and other relevant documents along with QA (Quality Assurance).
  • Review team member's activities / schedules for compliance (for review of preventive maintenance, calibration, building maintenance schedules)
  • Impart periodic GMP (Good Manufacturing Practices) refresher trainings to team along with recruitment, retention, supervision and motivation of personnel.
  • Responsible for monitoring of spares, ensuring availability of adequate spares, consumables and resources, and implement maintenance management system through SAP system.
  • Ensure 100% safety compliance and follow continuous improvement programs and by supporting safety and other functions to avoid any safety incidents
  • Educational Qualifications

    Required Education Qualification :

    Required Experience : 20 - 25 years

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    Senior Director • india, India

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