Sanofi
QCSupervisor(Microbiology)
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“QC Supervisor (Microbiology) at Sanofi. Skills: Microbiology, Quality Control, Laboratory Supervision, GMP Compliance, FDA Regulations. Overseeing daily operations of the quality control laboratory. Maintaining laboratory in compliance with GMPs and quality control processes”
Industry & Context.
Hands-on troubleshooting style; Investigating in a timely manner and resolving any quality control events, issues, or discrepancies; Implementing remediation actions from findings and CAPAs
What They're Looking For.
Must Have
minimum of 5 years hands-on experience in the laboratory, having been in supervisory roles for at least 2 years, Good knowledge of FDA regulations, cGMP is required
Nice to Have
Kubernetes a plus
What You'll Do.
Overseeing daily operations of the quality control laboratory
Maintaining laboratory in compliance with GMPs and quality control processes
Ensuring the use of validated methods and executing validation/transfer protocols
Managing and training laboratory staff
Conducting routine shopfloor of laboratory to identify improvement opportunities
Ensuring accurate and timely testing of received samples
Reviewing and approving laboratory test results and reports
Maintaining laboratory equipment
Ensuring the compliance of sampling and sample management
Handling sample management flows
Managing reference standards and reagents
Managing retention samples storage
Ensuring the training management of quality control samplers
Ensuring coordination of external/cross-site testing
Investigating and resolving quality control events
Implementing remediation actions from findings and CAPAs
Providing support during regulatory inspections and audits
Representing the site in Microbiology areas
Leading the microbiology section within QC to implement appropriate QC systems
and maintaining microbiological test methods
Writing investigation reports for Initial Laboratory Investigation (ILI)
Involving in Annual Product Quality Review Report (APQR)
Maintenance of specifications
standard operating procedures and other GMP documents
Conducting training on Sampling
Microbiological testing
Ensuring availability of workplace risk assessment and safe working procedures
How You'll Work.
Team & Collaboration
Managing and training laboratory staff; Ensuring coordination of external/cross-site testing; Representing the site in Microbiology areas; Participating in CoP and CoE; Focal point for Business Operation -Hubs; Conducting training on Sampling, Microbiological testing to other personnel
Communication Scope
Effective communication
Process & Methodology
Leading and driving equipment qualification activities, Monitoring and concluding operational excellence initiatives, Leading and overseeing investigations related to microbiological topics
Full Job Description
**Job title** : QC Supervisor (Microbiology) * Hiring Manager: Head of Site Quality * Location: Jurong, Singapore **About the Job** **Accountabilities:** * Overseeing daily operations of the quality control laboratory to ensure adherence to the committed scheduled plans * Maintaining his/her laboratory in compliance with the GMPs and quality control processes defined according to internal and external quality requirements and regulations * Ensuring the use of validated methods in his/her perimeter and executing any validation/transfer protocol as receiving unit * Managing and training laboratory staff, ensuring they follow best practices and safety guidelines * Ensuring his/her laboratory staff is qualified to perform the testing execution by maintaining the lab qualification matrix * Conducting routine shopfloor of laboratory to identify improvement opportunities * Ensuring accurate and timely testing of received samples according to his/her perimeter * Reviewing and approving laboratory test results and reports * Maintaining laboratory equipment by applying maintenance, qualification, and calibration plans to ensure accuracy and reliability of lab activities * Ensuring that his/her lab/facilities, lab instruments, are kept in a quality and safety status to ensure that they can be used appropriately * Leading the quality control sample management process to support the adherence of the test’s execution to the committed standard times * Ensuring the compliance of sampling and sample management with applicable regulatory requirements and company quality standards * Handling sample management flows from sampling to receiving and dispatching to the appropriate labs (including stability and EM sample management per plan) * Managing reference standards and reagents for the labs, in terms of stock, storage, validity to ensure test execution scheduling plans * Managing retention samples storage throughout their lifecycle management, in compliance with regulatory requiremen
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