Sanofi

QCSupervisor(Microbiology)

Singapore FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid candidates.

The Brief

“QC Supervisor (Microbiology) at Sanofi. Skills: Quality Control, Microbiology, Laboratory Management, GMP Compliance, FDA Regulations. Overseeing daily operations of the quality control laboratory. Maintaining laboratory in compliance with GMPs and quality control processes”

What You'll Achieve.

Ensure adherence to the committed scheduled plans; Ensure accuracy and timely testing of received samples; Ensure compliance of sampling and sample management; Ensure test execution scheduling plans are met; Ensure retention samples storage throughout their lifecycle management; Ensure the compliance of sampling and sample management with applicable regulatory requirements and company quality standards; Ensure that lab/facilities, lab instruments, are kept in a quality and safety status; Ensure safe working in all areas of work

Industry & Context.

Problems you'll solve

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 and cGMP is required, Good presentation skills and effective communication is required

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

Executing validation/transfer protocols

Managing and training laboratory staff

Ensuring laboratory staff is qualified

Conducting routine shopfloor of laboratory

Ensuring accurate and timely testing of received samples

Reviewing and approving laboratory test results and reports

Maintaining laboratory equipment

Ensuring lab/facilities and instruments are kept in a quality and safety status

Leading the quality control sample management process

Ensuring compliance of sampling and sample management

Handling sample management flows

Managing reference standards and reagents

Managing retention samples storage

Ensuring 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

Implementing appropriate QC systems

Leading and driving equipment qualification activities

and maintaining microbiological test methods

Identifying opportunities

and concluding operational excellence initiatives

Writing investigation reports for Initial Laboratory Investigation (ILI)

Leading and overseeing investigations related to microbiological topics

Involving in Annual Product Quality Review Report (APQR)

Preparation of environmental monitoring and water testing trend results

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

Ensuring safe working in all areas of work

How You'll Work.

Team & Collaboration

Coordinating external/cross-site testing; Providing support during regulatory inspections and audits; Representing the site in Microbiology areas; Participating in CoP led by global; Participating in CoE if requested; Ensuring local communication; Being focal point for Business Operation -Hubs if relevant for the site; Conducting training on Sampling, Microbiological testing to other personnel

Communication Scope

Good presentation skills; Effective communication

Process & Methodology

Equipment installation and qualification activities are done as per projects milestones

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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