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Shift Engineer Instrumentation

3 months ago

Bengaluru, Karnataka, India Syngene Full time

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.