QC Analyst I

Time left to apply: End Date: January 3, 2025 (30+ days left to apply)

Job Requisition ID: R2771185

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, preparation of standard operating procedures and equipment troubleshooting.

REPORTING RELATIONSHIP

The job holder reports to the QC Supervisor – Operations.

KEY ACCOUNTABILITIES

1. Participate in the Daily Capacity Management and +QDCI Level 1 sessions to ensure that site and department KPI’s are met.
2. Carry out analytical testing for Finished Product, Intermediates, Raw Material, In-Process Control and stability in compliance with specifications, analytical test methods, laboratory methods and pharmacopoeia requirements.
3. Prepare reagents and solutions in compliance with GLP and laboratory SOP requirements.
4. 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.
5. Perform analytical results review and audit trail review.
6. Assist in carrying out maintenance of laboratory equipment in compliance with established schedules.
7. Assist in carrying out on-the-job training for General Analytical Method to QC, by incorporating cGMP and safety aspects of the procedures.
8. 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.
9. Responsible for electronic raw data handling in compliance with regulations and guidelines.
10. Participate actively in efficiency management of the laboratory and contribute towards continuous improvement through teamwork, feedback and collaboration.
11. Participate in regulatory inspection and customer audits preparedness at site with regards to cGMP Quality and HSE aspects.
12. 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.
13. Play a pro-active role in ensuring the HSE standards & Life Saving Rule are adhered to.
14. Embrace Zero Incident Mindset and adopt the responsible of HSE protection policies and Life Saving Rules (LSR). Practice safe laboratory operations and ensure all HSE procedures are followed.
15. Other responsibilities that are not included in the above but are related to quality control and in accordance with internal guidelines and SOP.

CONTACT WITH OTHERS

Internal - Local and corporate colleagues

External - Suppliers/ Vendors/ Contractors

ABOUT YOU

A Diploma in Chemistry or any other related scientific discipline with minimum 3 years’ experience in pharmaceutical industry; or A fresh graduate from Degree in Chemistry 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.

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.

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.

Why 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.