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    Shift Engineer Instrumentation - bangalore, India - Syngene

    Syngene
    Syngene bangalore, India

    1 week ago

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    Description

    Primary Responsibility:

  • Overall adherence to safe practices and procedures of oneself and the teams aligned
  • Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company's integrity & quality standards
  • Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
  • Ensuring safety of self and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
  • Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time.
  • Compliance to Syngene' s quality standards at all times
  • Hold self-accountable for the achievement of safety goals
  • Govern the safety metrics from time to time

    • Specific Responsibilities:

  • Responsible for maintaining the facility, equipment in GMP compliance state as a team member of maintenance at Biologics Manufacturing.
  • Responsible to perform the preventive maintenance activities as per schedule.
  • Preparation and execution of equipment qualification (DQ, IQ, OQ) related documentations.
  • Responsible to prepare the master list and planners as per the schedule.
  • Planning and coordinating with vendor to carryout external AMC and equipment PM.
  • Monitoring and maintaining all utilities for BMP facility during shift and day to day operations.
  • Preparation of biologics EAM related SOPs related to maintenance.
  • Attending the breakdowns of equipment's for biologics.
  • Identifying and maintaining the critical spares.
  • Responsible for reconciliation and archival of documents.
  • Providing the trainings for service providers and contract engineers.
  • Responsible for clean utilities maintenance.
  • Daily monitoring of HVAC parameters.
  • Responsible for QMS closure. (CCF, CAPA & deviations)
  • Responsible to involve in client and regulatory audits, address the audit findings.
  • Responsible for preparation of quality department protocols related to EAM.
  • Supporting for preparation of General procedures and standard operating procedures of EAM.
  • Responsible for maintaining the BU approved layouts.
  • Responsible for completing the inhouse modifications/projects.
  • Responsible to perform the SAP activities.
  • Responsible to maintaining and closing the complaint slips on time.
  • Responsible to support for qualifying the vendors coordinating with QA.
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