QC Analyst I / Senior Analyst II - Micro Team at Sanofi Aventis US LLC

Singapore, , Singapore -

Full Time

Start Date

Immediate

Expiry Date

03 Apr, 26

Salary

0.0

Posted On

03 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Microbiological Testing, Analytical Test Methods, Laboratory Methods, GLP Compliance, cGMP Compliance, Teamwork, FDA Regulations, Pharmacopoeia Knowledge

Industry

Pharmaceutical Manufacturing

Description

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. Ready to get started? Roles and Responsible Carry out microbiological testing for APIs, stability samples, QC check of media, water and environmental samples in compliance with specifications, analytical test methods, laboratory methods and pharmacopoeia requirements. Prepare reagents, solutions and microbiological media in compliance with GLP and laboratory SOP requirements. Planning and assurance of cGMP compliant quality testing and documentation according to schedule. Ensure that analyses are carried out and reported in accordance with GLP (Good Laboratory Practices, completed on time and are consistent with the business requirements.) Carry out analytical results and audit trail review. Assist in carrying out maintenance of laboratory equipment in compliance with established schedules. Ensure GMP documents e.g. specifications, lab methods, standard operating procedures and other GMP documents (i.e. raw data, logbooks) in the laboratory are well maintained. Responsible for electronic raw data handling in compliance with regulations and guidelines. Participate actively in efficiency management of the laboratory and contribute towards continuous improvement through teamwork, feedback and collaboration. Participate in regulatory inspection and customer audits preparedness at site with regards to cGMP Quality and EHS aspects. Ensure compliance with HSE and quality policies and site procedures. Ensure safe working in the laboratory by practicing and communicating safety. Bring out unsafe conditions and acts / procedures. Familiar with Pharmacopoeia such as USP, EP requirement. Jobs Requirement A Diploma in Microbiology or any other related scientific discipline with minimum 3 years’ experience in pharmaceutical industry.; or A fresh graduate from Degree in Microbiology or any other related scientific discipline. Must be analytical, methodical, quality conscious and a good team player. Knowledge of FDA regulations and cGMP will be desirable. Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits. 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 QC Analyst is responsible for carrying out microbiological testing and ensuring compliance with specifications and regulatory requirements. They also prepare reagents and solutions, maintain laboratory equipment, and participate in audits and inspections.