Quality Control System Expert

About the role

The QC system expert is responsible to assist the Head of Quality Control to manage the execution and maintaining/updating of masterdata for QC digital tools. Incumbent would be the SME for QC digital Solutions (Core and Local) systems and drive continuous improvement initiatives to enhance quality control operational efficiency and effectiveness.

Key responsibilities

• Being representative of the site in the Business Operating Communities (BOC) related to QC digital core models, led by the global, in his/her scope and ensuring local communication.
• Executing local deployments of QC digital solutions (core model and local), in accordance with defined deployment plans and validation protocols.
• Issuing all local documentation related to QC digital solutions in scope, required to ensure their usage and maintenance in an appropriate way.
• Providing training and support of end-users on QC digital tools (in coordination with Sanofi global teams for core models).
• Maintaining and updating master data and end-user access to the QC digital tools, according to defined requirements and documentation.
• Develop and maintain routine preventive maintenance and calibration schedule of QC equipment and systems in enterprise CMMS system.
• Managing and ensure reliability of collected data within CMMS system for QC equipment maintenance activities and equipment history.
• Identify and resolve master data discrepancies within CMMS system for QC equipments.
• Support the execution of qualification and maintenance operations related to QC equipment of the quality control laboratory to ensure adherence to the committed scheduled plans.
• Contribute to the compliance of laboratory GXP asset qualification and maintenance with applicable regulatory requirements and company quality standards.

About you

• SME for QC digital Solutions (Core and Local) systems
• Knowledge of QC equipment management and CMMS systems
• Experience with Labware LIMS systems
• Ability to provide technical system administrator support for QC GXP laboratory computerized systems
• Knowledge of cGMP and Data integrity requirements
• Knowledge of HSE requirements
• Ability to perform tasks in accordance with cGMP and HSE requirements

About us

Sanofi-Aventis Singapore Pte Ltd, located in Singapore - Jurong.