Quality Control Support

Sanofi; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A global healthcare organization in Singapore is looking for a Quality Control Support professional to manage QC processes and contribute to compliance programs. The candidate should have a Bachelor’s or Master’s Degree and 5-8 years of experience in QC lab operations within the pharmaceutical industry. Responsibilities include oversight of QC events, regulatory inspections, and continuous improvement initiatives, ensuring adherence to Good Manufacturing Practices and guidelines.

Qualifications

• 5-8 years of experience in QC lab operations.
• Experience in managing internal audits and regulatory inspections.
• Strong understanding of pharmaceutical regulations and standards.

Responsibilities

• Represent QC processes led by the QMS team at site level.
• Manage follow-up and tracking of QC events and change controls.
• Contribute to an effective compliance program for QC.

Skills

Quality Control

Good Manufacturing Practices (GMP)

Regulatory Requirements

Analytical Skills

Communication Skills

Education

Bachelor’s or Master’s Degree in Pharmacy or related fields

Job description

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, 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