Quality Control Senior Analyst

About the job

Our Company:

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s life. We turn the impossible in to the possible by discovering, developing and delivering medicines and vaccines for millions of people around the world.

The Sanofi Modulus is at the cornerstone of our strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable and agile, leveraging new disruptive technologies, to better address biologics business challenges.

In this context, we are looking for one Quality Control Senior Analyst to participate and contribute in testing, sampling and other laboratory activities on site. This role requires the personnel to support shift hours.

Main responsibilities:

• Perform microbiological testing (Bioburden, Endotoxin, Growth Promotion Test, Microbial Identification etc) for water, raw material and product samples
• Perform water sampling of clean utilities system and environmental monitoring of controlled areas
• Support general laboratory activities, including housekeeping and staging of chemicals, reagents, and consumables
• Perform laboratory equipment maintenance and cleaning as and when required
• Participate and contribute to laboratory continuous improvement to enhance safety, operational efficiency, compliance and performance metrics
• Author/ revise QC related documents such as SOPs
• Support deviation, investigation and unexpected events writing as and when necessary, identify root cause and appropriate corrective and preventive actions
• Train newcomers for QC laboratory activities and testing
• Contribute to the achievement of laboratory performance targets and key metrics, including deviation/OOS rates and sample turnaround times
• Support the team during Health Authority inspections and internal or external audits

Education and experience:

• Bachelor’s Degree or Diploma in Pharmaceutical Sciences, Chemistry, Biology or related life Sciences or Technology with 4 to 6 years of experience in QC laboratory operations and microbiological testing.
• Knowledge of microbiological methods, including microbial identification and clean utilities testing, in the pharmaceutical or biotechnology industry is required.

Key technical competencies and soft skills:

• Knowledge of regulations and standards of the pharmaceutical industry
• Knowledge of the quality systems and associated technologies
• Good understanding of good laboratory practices, good documentation practice and data integrity requirements
• Strong interpersonal and communication skills
• Fluent in English speaking and writing