Quality Control Support at Sanofi Aventis US LLC

Singapore, , Singapore -

Full Time

Start Date

Immediate

Expiry Date

02 Apr, 26

Salary

0.0

Posted On

02 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Control, Compliance, Pharmaceutical Industry, Good Manufacturing Practices, Regulatory Requirements, Internal Audits, External Regulatory Inspections, Problem Solving, Communication, Investigation, Continuous Improvement, Documentation, Change Control, CAPAs, Lab Investigations, Event Management

Industry

Pharmaceutical Manufacturing

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 Pursue progress, discover extraordinary 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! Global Terms & Conditions and Data Privacy Statement Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube

Responsibilities

The role involves representing Quality Control (QC) for processes led by the Quality Management System (QMS) team and managing the follow-up and progress tracking of QC-related events. Additionally, the position includes contributing to compliance programs and supporting regulatory inspections.