Job Description

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.

• 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.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.