QC Support Expert

Job description

**Job title** : QC Support Expert

+ Hiring Manager: Quality Control Manager
+ Location: Aventis Pharma Manufacturing, Jurong, Singapore

**Transform Lives Through Excellence in Quality Control**

At Sanofi, we deliver 4.3 billion healthcare solutions to people every year, transforming the practice of medicine through breakthrough science that improves people's lives.

Our Manufacturing & Supply teams ensure this impact through flawless planning and meticulous attention to detail.

With your expertise in Quality Control, you'll help us protect more people from infectious diseases and bring hope to patients and their families worldwide.

**Your Impact**

As our Quality Control Support Expert, you'll be the cornerstone of laboratory excellence, ensuring compliance, efficiency, and continuous improvement in our quality control operations.

Your expertise will directly contribute to patient safety and product quality through:

**Key Responsibilities:**

**Equipment & Systems Management**

+ Ensure comprehensive lifecycle management of QC laboratory equipment
+ Lead qualification and maintenance operations for QC equipment
+ Establish metrics and monitor qualification activities to identify trends
+ Ensure all QC equipment are properly qualified and maintained
+ Serve as SME for Labware LIMS and collaborate with global functions

**Technical Leadership & Method Management**

+ Lead compendial compliance assessment and adherence for the QC laboratory
+ Support annual method reviews within the product review framework
+ Lead periodic analytical method control trend reviews and recommend improvements
+ Support the invalid assay trending program in the QC laboratory
+ Participate in Change Control Request facilitation for QC test methods

**Digital & Data Management**

+ Implement and maintain QC digital solutions (core and local models)
+ Ensure proper documentation, review, and approval of qualification deliverables
+ Record all required data and calculations in compliance with cGMP and Data Integrity requirements
+ Provide technical system administrator support for QC GXP computerized systems

**Quality & Compliance**

+ Maintain site validation master plan and procedures related to ALCM and CPV
+ Investigate and resolve quality control events promptly
+ Provide support during regulatory inspections and audits
+ Represent the site in Communities of Practice (CoPs) led by global teams
+ Deputize as QC Manager when required

**Safety & Continuous Improvement**

+ Ensure compliance with HSE policies and site procedures
+ Embrace Zero Incident Mindset and adhere to Life Saving Rules
+ Lead initiatives for continuous improvement in QC support processes
+ Practice and communicate laboratory safety standards

**What You Bring**

+ Strong chemistry background with technical expertise in laboratory equipment qualification and analytical method validation
+ Experience with LIMS and laboratory computerized systems
+ Knowledge of cGMP, data integrity requirements, and regulatory standards
+ Excellent problem-solving skills and attention to detail
+ Strong communication and collaboration abilities
+ Commitment to quality, safety, and continuous improvement

**Why Join Us?**

Join our team and be part of a mission that matters.

At Sanofi, you'll have the opportunity to grow professionally while making a meaningful difference in patients' lives.

Your expertise in quality control will directly contribute to our ability to deliver safe, effective healthcare solutions globally.

**Ready to get started?

Apply now and help us chase the miracles of science to improve people's lives.**

**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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/)

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 (https://youtu.be/96EwNjb1TLo)

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 (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)

Required Skill Profession

Other General