Senior QC Analyst II KEY ACCOUNTABILITIES KEY ACCOUNTABILITIES

Job description

Carry out QC analyses in compliance with Laboratory and Analytical Methods ensuring quality, cGMP, heath, safety and environmental standard are met. Assist in other functions such as documentation and preparation of standard operating procedures. Capable of working in shift.

REPORTING RELATIONSHIP

The job holder reports to the QC Supervisor.

KEY ACCOUNTABILITIES

Assist in carrying out on the job training of other QC Analysts, incorporating cGMP and safety procedures.

Perform Carry out analytical testing in compliance with specifications, Analytical Methods, Laboratory Methods and pharmacopoeia requirements.

Assist in monitor the calibration and maintenance program for laboratory instruments / equipment and ensure compliance with established schedules.

Assist in qualification of laboratory equipment and validation of analytical methods.

Ensure that analyses are carried out and reported in accordance with GLP (Good Laboratory Practices). Ensure that analyses are completed on time and are consistent with business requirements.

Assist in conducting OOS and atypical results investigation.

To ensure that qualification, preventive maintenance and calibration of laboratory equipment are carried out.

Report and trend test results.

Planning and assurance of cGMP compliant quality testing and documentation according to schedule.

Prepare laboratory reagents in compliance with GLP and laboratory SOP requirements. Source reagents / laboratory consumables keeping in view department budget targets.

Assist in other functions such as preparation of standard operating procedures and Assist documentation etc and participate in departmental activities as and when required. Maintenance and development of all required laboratory documents (i.e. raw data sheets, log books).

Responsible for electronic raw data handling in compliance with regulations and guidelines.

Responsible for inspection and audit preparedness with respect to cGMP and EHS issues.

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.

KNOWLEDGE/EXPERIENCE REQUIRED

A Diploma graduate in chemistry/ chemical process technology / bio-process technology; or ITE graduate with a minimum of 3 years’ hands-on experience.

Must be analytical, methodical and quality conscious.

Good knowledge of FDA regulations and cGMP.

Must be resourceful, conscientious, dedicated and a good team player

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.