Quality Control Analyst I
Sanofi
- Singapore
- Permanent
- Full-time
- 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
- Internal
- Local and corporate colleagues
- External
- Suppliers/Vendors
- Waste disposal contactor
- 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