Position: Quality Control Support
Hiring Manager: Manager, QC Raw Material & Lab Service
Location: Tuas, Singapore
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 Evolutive Facilities to our global industrial footprint. These production units (EVF) 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 Evolutive Facilities (EVF) will enable more responsive and flexible manufacturing across multiple vaccine and biological platforms including mRNA, while minimize our impact to the environment. Our EVFs will help improve people’s lives by giving them faster access to more treatments.
Main Accountabilities:
Representing QC for the processes led by QMS team at site level
Managing the consolidated follow-up and progress tracking of events (eg deviation, lab investigations), change control and CAPAs, related to QC, coordinating with respective QC areas and other involved functions, to ensure they are managed and closed as committed
Contributing to develop, implement, and maintain an effective compliance program for QC in accordance with the site Compliance head
Ensuring issuance and approval of appropriate local quality control documentation, when required to support the QMS processes applicable to QC, in alignment with the site QMS
Investigating on a timely manner and resolving any quality control events, issues or discrepancies from his/her perimeter. Implementing remediation actions from findings and CAPAs
Providing support during regulatory inspections and audits
Leading initiatives for continuous improvement in QC, in coordination with QC excellence team
Education, Experience/Technical Skills:
Bachelor’s or Master’s Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology or related life Sciences or Technology with about 5-8 years of experience in QC lab operations, method validation and equipment qualification, raw materials release and Quality Assurance related.
Experience in quality control within the pharmaceutical industry, including knowledge of Good Manufacturing Practices (GMP) and regulatory requirements
Experience in managing internal audits and external regulatory inspections, including preparation, execution, and follow-up
In-depth understanding of pharmaceutical regulations, guidelines, and standards (e.g., FDA, EMA, ICH)
Ability to analyze complex compliance issues, identify root causes, and develop effective solutions
Proficiency in identifying issues and implementing effective solutions to resolve quality control problems
Strong verbal and written communication skills to effectively convey compliance requirements and updates to various stakeholders
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!
