Sanofi
pharmaceutical
M&S-QualityControlExpertMicrobiologyIFB
Neural analysis suggests this role is
optimal for Senior candidates.
“M&S-Quality Control Expert Microbiology IFB at Sanofi. Skills: Microbiology Quality Control, analytical expertise, GMP, cGMP, HSE. establishing the Microbiology Quality Control laboratory. develop procedures and documents to commission equipment and analytical methods”
What You'll Achieve.
transition to routine operations; project hit the milestone in a compliance manner; expected objectives, performances, HSE, Quality
Industry & Context.
troubleshooting and investigations related to analytical methods and laboratory technologies; risk analysis
What They're Looking For.
Must Have
Degree in Microbiology/ Pharmacyiochemistry or Equivalent, Minimum of 5 years of pharmaceutical or biotechnological industry experience, practical experience in microbiology analytical method transfer/verification and/or instrument qualification and validation, Experience in a project leadership positions with a proven track record of delivery and compliance, Experience in scientific and technical writing, Effective oral and written communication skills, Proficient with typical microbiological techniques, In-depth understanding of GMP principles and data integrity requirement, GMP and health-regulated requirements, International and FDA experience
Nice to Have
MSc or PhD level qualification in science, knowledge & experience automation and/or LIMS, innovative thinking, Familiarity with strategic planning, balanced judgment and risk analysis
What You'll Do.
establishing the Microbiology Quality Control laboratory
develop procedures and documents to commission equipment and analytical methods
validation and test activities
Provides microbiological analytical expertise for projects
troubleshooting and investigations related to analytical methods and laboratory technologies
Creates and reviews protocols and reports related to analytical verification/validation/transfer activities and qualification measures
reviews and maintains precise standard operating procedures for analytical methods
Ensures the performance of all tasks in accordance with cGMP and HSE requirements
Ensures the documentation of all required raw data
calculations and information
Timely informs about quality or HSE-relevant events
Ensures proper documentation of deviations
non-conformities and corrective actions
Ensures GMP-compliant execution and documentation of quality tests and workflows for pharmaceutical products
delivery the microbiology quality control lab aspects of the project
Standardize operational processes and cost management with a focus on continuous improvement
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
Process & Methodology
project leadership positions, delivery of the microbiology 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 Microbiology Quality Control expert will work on establishing the Microbiology 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 team consisting of internal and/or external analysts and/or technicians to execute transfer, qualification, validation and test activities to support project hit the milestone in a compliance ma
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