Sanofi
healthcare
QCManager,Microbiology
“QC Manager, Microbiology at Sanofi. Skills: Microbiology laboratory management, cGMP compliance, Quality Control. Lead and manage the day-to-day operations of the Microbiology team. ensuring performance and compliance with cGMP, HSE, and regulatory requirements”
What You'll Achieve.
ensuring performance and compliance with cGMP, HSE, and regulatory requirements; ensuring targets for quality, safety, and productivity are met
Industry & Context.
investigation and resolution of Out-of-Specification (OOS) results; investigation and resolution of deviations; investigation and resolution of CAPAs
Ability to work collaboratively in a fast-paced environment
What They're Looking For.
Must Have
Degree in Microbiology, Life Sciences, or a related scientific discipline, Proven experience in a pharmaceutical or biopharmaceutical microbiology laboratory environment for about 10-12 years, people management experience, Ability to work collaboratively in a fast-paced environment, knowledge of microbiological testing methods, knowledge of cGMP regulations (EU/US), knowledge of quality management systems, Experienced in Quality Management, Experienced in Risk-Based Approach, Experienced in Operational Excellence, Experienced in Safety Management, leadership, communication, team management ability, ability to drive continuous improvement, ability to lead cross-functional collaboration, Proficiency in English
What You'll Do.
Lead and manage the day-to-day operations of the Microbiology team
ensuring performance and compliance with cGMP
and regulatory requirements
Drive consistent planning
and improvement of microbiological testing activities
and development to a team of QC analysts
Ensure timely investigation and resolution of Out-of-Specification (OOS) results
Monitor and report on the team’s KPIs
Ensure all laboratory equipment
and systems are qualified
and maintained in a state of compliance
Support internal and external audits and regulatory inspections
How You'll Work.
Team & Collaboration
Collaborate cross-functionally with Manufacturing, Quality Assurance, and Regulatory Affairs to support batch release and regulatory submissions; lead cross-functional collaboration
Communication Scope
communication
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