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Water System Operator

Water System Operator

SyngeneBengaluru, Karnataka
6 days ago
Job description

Primary Responsibility :

  • Responsible for performing the activities related to the Engineering & maintenance at Biologics Unit 03.
  • Responsible for GMP compliance and error free operations.
  • Follow all EHS requirements at all time s in the workplace ensuring individual and plant safety.
  • Ensuring all assigned mandatory trainings related to data, integrity, health and safety measures are completed on time.
  • Ensuring compliance to quality systems.
  • Develop and contribute to development of procedures, practices and setup that ensures safety operations compliant to company and regulatory norms.
  • Compliance to current good manufacturing practices
  • Adherence to Standard Operating Procedures and safety requirements.

Specific Responsibilities :

  • Responsible to perform the preventive maintenance as per the Schedule.
  • Preparation and execution of equipment qualification (DQ, IQ, and OQ) related documentations.
  • Responsible to perform the validation, requalification activities as per the schedule.
  • 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 maintenance.
  • Attending the breakdown of equipment’s for BMP.
  • 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 the HVAC parameters.
  • Responsible for QMS closure (CCF, CAPA and Deviations).
  • Responsible to involve client and regulatory audits, address the audit findings.
  • Compliance to current good manufacturing practices.
  • Adherence to Standard operating procedures and safety requirements.
  • Responsible for preparation of quality department protocols related to EAM.
  • Support 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.
  • Responsible to maintain and closing the complaint slips on time.
  • Responsible to support for qualifying the vendors coordinating with QA.