About the job
Sanofi has decided to invest into a new large state-of-the art facility for Insulin Drug Substance in Beijing, China (IFB). For this green field operation, we’re enhancing our legacy of excellence and build on decades of expertise on the whole value chain of insulin manufacturing. The new facility will be designed as a fully automated, green, modern, and state-of-the-art biologics facility. A large global and highly cross-functional program organization will be established to lead and execute the program until commercial routine manufacturing.
Meet Katrin, our Global Program Leader, and discover how we’re transforming insulin production. Watch now!
Position Overview
The Quality Control Analyst will contribute to the execution of IFF IPC laboratory topics of the TIER 1 program lifecycle from feasibility to PPQ (Process Performance Qualification) including final approval.
This role will work on establishing laboratory activities as qualification of equipment, transfer of analytical methods in QC in the InsuLINK project at IFB during the planning phase, qualification through to final approval and transition to routine operations. Together with other Q-functions, the incumbent will support to develop procedures and documents and to commission equipment and analytical methods in accordance with applicable GMP requirements, internal quality standards, and regulatory specifications. In addition to providing support, the main work will focus on cary out the practical activities of equipment commissioning and method transfer.
The Quality Control Analyst will report to the Quality Control Lab Supervisor and dotted line to the Quality Control Expert in the project early phase.
Main responsibilities:
- Participation in the establishment, qualification and commissioning of the QC laboratory in IFB.
- Implementation of chemical and chemical-physical bioanalytical tests as part of the DS release, incoming material release, in-process controls, clean utility monitoring and cleaning validation of insulin drug substance manufacturing.
- Supporting analytical method transfers and verification/validation activities.
- Executing analytical testing in a timely manner, ensuring adherence to the committed scheduled plans
- Performing the QC data review of executed tests by other analysts in a timely manner, ensuring adherence to the committed scheduled plans
- Conscientious documentation of all measurement results, raw data and calculations according to cGMP and data integrity requirements.
Participation in the preparation and review of laboratory specifications, methods, procedures, templates, protocols and reports.
- Implementation of device (re-)qualifications under supervision.
- Calibration and maintenance of the assigned equipment or coordination of it, e.g. by external service providers, including the associated documentation.
- Ensuring that he/she is trained and qualified to the assigned analytical testing that requires to be qualified
- Assist in troubleshooting and investigating analytical issues.
- Receiving, storing, documenting, handling and disposing of reagents and reference standards. Managing reagents, column, reference standards and other testing relates consumables stocks to ensure proper amounts can be used. Manage archives of analytical columns.
- Maintenance of documents, e.g. form sheets, test instructions, SOPs, SOP attachments, Logbooks
Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records, related to these tasks
- Informing his/her manager of any quality or HSE event (deviations, OOx,…) in a timely manner to ensure investigation and impact assessment are performed appropriately
- Executing assigned CAPAs related to remediation plans, continuous improvements
- Execute other works which is assigned by the line manager.
About you
Experience
- Degree in Chemistry/Pharmacy/Biochemistry or Equivalent.
- Associate degree at the minimum. Preferably bachelor or above.
- Minimum of 2 years of pharmaceutical, food or biotechnological industry experience.
- Experience in quality control within the pharmaceutical industry, including knowledge of Good Manufacturing Practices (GMP) and regulatory requirements
- Experience or wiliness in in-process control analysis of active ingredients is an advantage.
- Experience in carrying out equipment qualification or method validation/verification/transfer is an advantage.
Soft Skills:
- Precise, independent and structured way of working
- Proactive Problem-Solving and communication
- Resilience
Technical Skills:
- Professional experience in the field of typical instrumental analysis (HPLC, GC, UV,IR, titration, TOC) and wet chemistry analysis.
- Ability to analyze complex data and laboratory results to make informed decisions and identify areas for improvement
- Keen attention to detail to ensure accuracy in testing, reporting, and compliance with regulatory requirements
- Proficiency in identifying issues and implementing effective solutions to resolve quality control problems
Languages:
- Familiar with academic English/German and Mandarin across at least two modalities: reading and writing.
