About the job

Main responsibilities

The Quality CSV D&Q Manager IFB (Computerised System Validation, Design & Qualification, Insulin facility Beijing) is responsible for ensuring that all aspects of CSV, Data Integrity and validation activities for the project, including design, qualification of facilities, critical utilities, equipment, and computerized systems, automation and digitalization, are executed on time and in accordance with the C&Q / Validation Master Plan, local and global requirements, and applicable regulations.

As an integral part of the project quality team, this position has overall responsibility for participating in project workstreams, ensuring proper execution of design/qualification/validation strategies as well as providing support and guidance for quality processes and procedures.

This role is expected to work independently and with a level of autonomy and authority in decision-making to ensure on-going compliance against approved documents and current Good Manufacturing Practices across the project during conceptional, basic and detailed design, construction C&Q, PQ, Validation and future site organizations until final approval.

Management:

• Ensures the project is performed according to the Sanofi Standards and Good Practices.
• Ensures regular reporting to the Global Quality D&Q Lead.

Commissioning & Qualification and Validation:

• Responsible for the project CSV, Data Integrity, C&Q&V strategy execution, C&Q&V plans and System impact assessment.
• Responsible to drive Data Integrity Strategy in IFB in collaboration with Automation, MSAT, Operations and CQ team, with focus on data integrity in GxP alarms, electronic Batch release, Quality data processing in IFB.
• Oversee as Quality the Strategy and Execution of Automation and computerized Equipment Design, Automation C&Q and integration in C&Q&V, code testing, integration and documentation by external vendors.
• Ensure Automation qualification and CS Validation in IFF compliant to Annex 1, Annex 15, GAMP 5 and applicable regulations
• Responsible for the preparation and the execution of Automation DQ, SAT, FAT, IQ, OQ and nP-PQ protocols, final CQ reports and VMP
• Interacts with IFF to keep benchmark and best practices cross-fertilization.
• Responsible for the consistency of the turnover package to system owners.

Project Control, Cost & Schedule:

• Supporting the regular collection of actual quality Data Integrity and C&Q project cost and progress.
• Ensures the project compliance with Sanofi Cost & Schedule Policies and Standard.

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