Quality Analyst Microbiology

Quality Analyst Microbiology

Sanofi

Waterford, Ireland

About the Job

As Quality Analyst Microbiology within our QC Team, you’ll provide chemistry support and knowledge to the QC team and to other departments.

Ready to get started?

This position also includes performing QC testing by following approved methodology to assure that the safety, quality, purity and stability of the products, components and in-process stages are in compliance with approved specifications.

Main responsibilities

• Provide Microbiology support to the Quality Assurance, Qualified Persons, Validation and Manufacturing departments as well as other areas on site.
• Documentation review and batch release review.
• Provide technical guidance and expertise to QC Microbiology Team and external departments. In particular, close contact maintained with Validation, Manufacturing, Planning and Quality Assurance.
• Execution of QC Microbiology testing (water sampling, water testing, environmental monitoring, compressed air/nitrogen and more) as required.
• Compliance with cGMP and Standard Operating Procedures and pharmacopeias at all times.
• Actively contribute to continuous improvement initiatives in the lab.
• QC Microbiology representation at cross functional meetings.

About you

• Experience: experience within a QC department in a Pharmaceutical or GMP facility; Experience in Microbiological techniques; understands Key Performance Indicators.
• Soft and technical skills: Excellent communication skills, natural influencer, and ability to work effectively in cross -functional teams as well as working solo; Knowledge of quality management systems (e.g. Veeva/Qualipso/Trackwise); Knowledge of lab management systems (e.g. LUNA); Be a motivated, ambitious and goal oriented individual.
• Education: Bachelors Degree in a Scientific discipline (Biology, Chemistry, Biotechnology, Biochemistry or Food science preferred).