Calibration team lead

7 days ago


Bengaluru, Karnataka, India Syngene Full time

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.
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