Expert , QC

About The Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Sanofi has added two new Modulus Facilities to our global industrial footprint. These production units represent the future of manufacturing. They allow us to increase our capacities while making production more flexible and respectful of the environment.

Fully digitalized, our Modulus Facilities will enable more responsive and flexible manufacturing across multiple vaccine and biological platforms including mRNA, while minimize our impact to the environment. Our facilities will help improve people's lives by giving them faster access to more treatments.

In this context, we are seeking a highly motivated

Expert, QC

to join our team and play a key role in establishing and operating a state-of-the-art QC laboratory at our new Singapore site. This position offers an exciting opportunity to contribute to the successful start-up of a new facility and ensure compliance with global quality standards.

Main Responsibilities

Responsible for analytical method transfer and method validation in the QC laboratory, to ensure robust test methods are implemented on time to support product testing in meeting manufacturing & supply deliverables. The analytical methods include (but not limited to) UPLC, HPLC, GC, Electrophoresis, ELISA and spectrophotometry. Work closely with Analytical Science for method transfer/ validation strategy alignment, timely completion of the applicable gap assessment, method transfer plan, method validation protocol and technical report. Work closely with the Tech Transfer Manager to ensure adherence to project timelines and critical milestones are met during New Product Introduction (NPI) initiatives. Primary QC representative to provide QC tech transfer updates, highlights and challenges to cross-functional team members during Tech Transfer Tier meetings. Implementation of product stability program for the site. Partner with Quality Stability and Statistics team to ensure timely completion and approval of the stability protocols and reports. Overall responsible for the Analytical Life Cycle Management for the QC laboratory. Perform method control trend review/ investigation and data evaluation on method performance, recommend method improvements where appropriate. Provide technical leadership and guidance for the successful completion of major laboratory projects. Represent QC as technical contact/ subject matter expert on diverse topics in relation to analytical test methods. Involvement in troubleshooting and investigations/ deviations which may require in-depth analysis of test methods. Participate in Change Control Request facilitation and management in relation to QC test methods. Responsible for annual method review in the framework of annual product review. Responsible for the invalid assay trending program in the QC laboratory. Oversight role to compendial compliance assessment for the QC laboratory.

Education And Experience

Bachelor's or Master's Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology or related life Sciences or Technology with about 7-10 years of experience in analytical method validation and method transfer in the pharmaceutical or biotechnology industry.

Key Technical Competencies And Soft Skills

Knowledge of regulations and standards of the pharmaceutical industry, Global Quality policies and Data Integrity Requirements. Knowledge of the quality systems and associated technologies. Good understanding of good laboratory practices, good documentation practice and data integrity requirements. Experienced in analytical method validation/ method transfer. Strong interpersonal relationships to establish the partnerships necessary for the development of the Quality culture. Independent, discipline and assertiveness in decision-making and execution in laboratory start-up activities. Good communication skills to advocate QC positions with other functions, including during inspections. Keen to learn new technologies. Continuous improvement mindset. Fluent in English speaking and writing.

null

Back to blog

Other Jobs To Apply

No other job posts for this day.

Common Interview Questions And Answers

1. HOW DO YOU PLAN YOUR DAY?

This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

5. HOW DO YOU PROCESS INFORMATION?

Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

8. HOW TO PRIORITIZE WORK?

The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...