QC Specialist

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 QC Specialist 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

1. Environmental Monitoring Operations

• Perform routine Environmental Monitoring (EM) activities, including sampling, data review, trending, and documentation in accordance with GMP requirements.

• Develop EM sampling plans for routine monitoring, BSC EM sampling, isolator EM sampling, aseptic qualification, and equipment qualification activities.

• Coordinate and manage the EM sampling schedule to ensure all routine and ad hoc activities are completed on time.

• Review EM sampling results in LIMS to ensure data accuracy, completeness, and compliance with GMP requirements.

• Forecast media requirements and provide procurement estimates to ensure sufficient inventory for EM activities.

2. Equipment & Qualification

• Lead qualification and requalification (IQ/OQ/PQ) activities for EM equipment.

• Review and approve qualification documents, protocols, and reports.

• Manage the calibration of air samplers and particle counters, including scheduling, vendor coordination, and documentation.

3. Quality & Compliance

• Lead and support investigations related to EM excursions, deviations, contamination events, CAPAs, and change controls.

• Act as the document owner for EM-related SOPs, Work Instructions (WIs), and other GMP documents, ensuring they remain current and compliant.

• Perform quarterly EM trending to monitor environmental performance and support GMP compliance.

• Manage the microbial isolate conservation program, including isolate selection, culture maintenance, and trending.

• Support validation activities

4. Technical Leadership & Support

• Act as the Subject Matter Expert (SME) for Environmental Monitoring, providing technical guidance and troubleshooting support to EM personnel and cross-functional teams.

• Serve as the EM trainer by developing and delivering training to ensure personnel competency and compliance.

• Maintain competency in QC Microbiology laboratory bench testing to provide operational support when required.

• Participate in cross-functional meetings to coordinate EM-related activities and provide technical input.

• Work closely with Manufacturing, Engineering, Validation, QA, and other stakeholders to support EM-related activities and ensure GMP compliance.

About You

Education and experience 

• Education: Degree in Microbiology, Life Sciences, or a related scientific discipline
• Experience: Proven experience in a pharmaceutical or biopharmaceutical microbiology laboratory environment for about 5-8 years. Ability to work collaboratively in a fast-paced environment
• Technical Skills: Strong knowledge in Environmental Monitoring and cGMP regulations (EU/US).
• Functional Skills: Experienced in Risk-Based Approach and Operational Excellence
• Soft Skills: Good communication capabilities; ability to drive continuous improvement and lead cross-functional collaboration
• Languages: Proficiency in English

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!