Sanofi
pharmaceutical
M&S-QualityControlExpert-IFB
Neural analysis suggests this role is
optimal for Senior candidates.
“M&S - Quality Control Expert - IFB at Sanofi. Skills: Quality Control, analytical expertise, GMP, project leadership. establishing the Quality Control laboratory. develop procedures and documents to commission equipment and analytical methods”
What You'll Achieve.
transition to routine operations; support project hit the milestone in a compliance manner; delivery the quality control lab aspects of the project, within the allocated budget, schedule and the expected objectives, performances, HSE, Quality; Ensure the project is performed according to the Sanofi Standard and Good Practices
Industry & Context.
troubleshooting; investigations related to analytical methods; risk analysis
HSE requirements, occupational safety guidelines, work accidents, occupational diseases
What They're Looking For.
Must Have
Minimum of 5 years of pharmaceutical or biotechnological industry experience, Minimum of 2 years in project leadership positions with a proven track record of delivery and compliance, Proficient with typical analytical techniques and software, In-depth understanding of GMP principles and data integrity requirement, GMP and health-regulated requirements, International and FDA experience
Nice to Have
Ideally MSc or PhD level qualification in science, preferably with practical experience in analytical method transfer/verification and/or instrument qualification and validation, Preferably with the knowledge & experience in PAT, automation and/or LIMS, Experience in scientific and technical writing, Effective oral and written communication skills, innovative thinking, Familiarity with strategic planning, balanced judgment and risk analysis
What You'll Do.
establishing the Quality Control laboratory
develop procedures and documents to commission equipment and analytical methods
functional leadership of a team consisting of internal and/or external analysts and/or technicians
execute the rest of transfer
validation and test activities
Provides analytical expertise for projects
Creates and reviews protocols and reports related to analytical validation/transfer activities and qualification measures
reviews and maintains precise standard operating procedures for analytical methods
Ensures the performance of all tasks (initially especially equipment qualifications
analytical transfers) in accordance with cGMP and HSE requirements
Ensures the documentation of all required raw data
calculations and information to comply with cGMP and data integrity requirements
Timely informs the LM about quality or HSE-relevant events (deviations
Ensures proper documentation of deviations
non-conformities and corrective actions
Ensures GMP-compliant execution and documentation of quality tests and workflows for pharmaceutical products
How You'll Work.
Team & Collaboration
Cross-functional collaboration; Collaborates closely with the sending unit in Frankfurt, MSAT and global SME network
Communication Scope
Effective oral and written communication skills; Communication skills; Proficient in academic English/German and Mandarin across all four modalities: listening, speaking, reading and writing
Process & Methodology
project leadership positions, delivery, compliance, strategic planning, quality control lab aspects of the project, within the allocated budget, schedule and the expected objectives, performances, HSE, Quality
Full Job Description
**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!_](https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.douyin.com%2Fuser%2FMS4wLjABAAAAD1va6zT5_jjCchcfhkayLNl8dXAdtWcg-3fhgpGDjZk%3Fmodal_id%3D7477419452397587727%26relation%3D0%26vid%3D7358336359246892307&data=05%7C02%7CLucia.Kong%40sanofi.com%7C576b61229b4e4f39f75208dd5a3fd313%7Caca3c8d6aa714e1aa10e03572fc58c0b%7C0%7C0%7C638765952344347098%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=WRX%2BePMJSyZXdpk0Kn9Qj23MYT0sFprEhZ8%2Bd%2BDsxtw%3D&reserved=0) _**Position Overview**_ The Quality Control expert will work on establishing the Quality Control laboratory at IFB during the planning phase, qualification through to final approval and transition to routine operations. Together with other Q-functions, the incumbent will develop procedures and documents to commission equipment and analytical methods in accordance with applicable GMP requirements, internal quality standards, and regulatory specifications. As the project proceeds, this role is expected to evolve to functional leadership of a team consisting of internal and/or external analysts and/or technicians to execute the rest of transfer, qualification, validation and test activities to support project hit the milestone in a compliance manner reg
Applying for this M&S - Quality Control Expert - IFB role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Sanofi?
Real rants from real employees. Read before you apply.