Shift Incharge

Safety:

To place safety at par with business performance with Shared responsibility and accountability, including following safety guidelines, procedures, and SOPs in letter and Spirit.

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 for Calibration system handling.
• Responsible for instrumentation handling in unit -03.
• 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.