Quality Control Expert

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 Quality Control Expert 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

• Support the routine operations of the new QC laboratory based in Singapore:

Method Validation & Verification

• Design, execute, and document method validation studies for raw material testing in accordance with regulatory requirements

• Perform compendial method verification for USP, EP, JP, and other pharmacopeial methods to ensure suitability for intended use

• Establish acceptance criteria, accuracy, precision, specificity, linearity, detection limits (LOD), and quantitation limits (LOQ)

• Lead method transfer activities between manufacturing sites

• Prepare and review validation protocols, reports, and technical documentation
  

Raw Material Testing & Release

• Review and approve analytical data to support raw material release decisions

• Investigate out-of-specification (OOS) and out-of-trend (OOT) results
  

Technical Expertise & Continuous Improvement

• Serve as subject matter expert for analytical techniques including HPLC, GC, UV-Vis, titration, wet chemistry, and spectroscopy

• Troubleshoot analytical method issues and implement corrective actions

• Drive continuous improvement initiatives for testing efficiency and method robustness

• Evaluate and implement new analytical technologies and methodologies
  

Quality & Compliance

• Ensure all testing activities comply with cGMP, GDP, and regulatory requirements (FDA, EMA, ICH)

• Support internal and external audits, inspections, and regulatory submissions

• Author and review SOPs, work instructions, and quality procedures

• Participate in change control, deviation investigations, and CAPA processes
  

Collaboration & Leadership

• Provide technical training and mentorship to QC analysts

• Support new product introductions and process improvements

Education and experience

• Bachelor’s or Master’s Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology or related life Sciences or Technology with about 10-12 years of experience in QC lab operations and testing

• Experience in raw material method validation and method transfer in the pharmaceutical or biotechnology industry preferred.

Key technical competencies and soft skills:

• Good understanding of good laboratory practices, good documentation practice and data integrity requirements.

• Hands-on experience with analytical techniques such as HPLC, GC, ICP-MS, UV-Vis, FTIR, Karl Fischer (KF), spectroscopy, and wet chemistry methods.

• Strong understanding of method validation, transfer, and regulatory requirements (ICH, USP, EP).

• Experience in regulatory audits will be advantageous.

• Strong interpersonal relationships and good communication skills to establish partnerships with key stakeholders.

• Excellent documentation skills and familiarity with electronic systems (LIMS, Empower).

• Ability to work collaboratively in a fast-paced start-up environment.