Job Information
Sanofi Group Quality Control Analyst I, APM in Singapore
Job title: Quality Control Analyst I
Location: Singapore
Hiring Manager: QC Supervisor – Operations.
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.
Job Purpose
Carry out QC analysis in compliance with Laboratory and analytical test methods ensuring quality, cGMP, Health, Safety and environmental standards are met. Assist in other functions such as documentation, and preparation of standard operating procedures.
Main responsibilities
Assist in carrying out on-the-job training to other QC analysts, by incorporating cGMP and safety aspects of the procedures.
Participate in the Daily Capacity Management and +QDCI Level 1 sessions to ensure that site and department KPI’s are met.
Carry out analytical testing for Finished Product, Intermediates, Raw Material (if required) in compliance with specifications, analytical test methods, laboratory methods and pharmacopoeia requirements.
Ensure that analyses are carried out on time and are consistent with the business requirements.
Assist in carrying out maintenance / calibration records of laboratory instruments / equipment in compliance with established schedules.
Assist in improving and maintaining test methods and equipment (i.e. qualification, validation and transfer).
Prepare reagents and solutions in compliance with GLP and laboratory SOP requirements.
Participate actively in efficiency management of the laboratory and contribute towards continuous improvement through teamwork, feedback and collaboration.
Planning and assurance of cGMP compliant quality testing and documentation according to schedule.
Maintenance of specifications, lab methods, standard operating procedures and other GMP documents in the lab.
Maintenance and development of all required laboratory documents (i.e. raw data sheets, logbooks).
Responsible for electronic raw data handling in compliance with regulations and guidelines.
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.
Other responsibilities that are not included in the above but are related to quality control and in accordance to internal guidelines and SOP
Contact with Others
Internal
- Local and corporate colleagues
External
Suppliers/Vendors
Waste disposal contactor
About You
Diploma in Chemical Process Technology / Bio-Process Technology’ with minimum 3 years’ experience; of GCE ‘A’/’O’ level with minimum of 5 years relevant experience.
Must be analytical, methodical and quality conscious.
Knowledge of FDA regulations and cGMP will be desirable.
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) !
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)