Responsibilities

You are the QC reference for all aspects of microbiology and sterility.
You define, develop and validate microbiological analytical methods for controlling production facilities (clean rooms, aseptic lines, etc.) and products such as reagents, active ingredients or drugs. You write and implement validation protocols and reports.
You write SOPs for microbiological QC tests and use related QC equipment.
You are responsible for the operational implementation and follow-up of analytical QC release and stability tests for microbiological analyses (endotoxins, bioburden and sterility) on Trasis products.
You identify equipment and infrastructure requirements for microbiological testing at Trasis.
You are responsible for the operational implementation and follow-up of analytical QC tests on Trasis’ production facilities for consumables, active ingredients and drug products: clean room (environmental monitoring), aseptic line and water loop.
You carry out microbiological analysis activities in accordance with the required quality standards and grades. You carry out microbiological trend analyses (microbial load and flora).
You are in charge of critical analysis of test results and assessment of compliance with acceptance criteria.
You propose and implement new quality control technologies by identifying opportunities for innovation (technology watch).
You initiate and monitor quality elements such as deviation, OOS, change control, CAPA. In the event of non-conformity, you identify the cause, assess the potential impact and propose corrective and preventive actions.
You take part in reagent management and in maintaining the QC laboratory’s 5S.

Profile

You have a Bachelor’s or Master’s degree in microbiology/biology/agronomy/biochemistry.
You have a working knowledge of GMP standards and a good understanding of industrial microbiology.
You have at least 3 years’ experience in a similar position.
You have a good command of spoken and written English.
You have a good command of the Office Suite.
You are autonomous, pragmatic and proactive.
You are able to synthesize and analyze information.
You are precise and rigorous.
You are a team player.
You are proactive, organized and have a sense of priorities.

Do you want to become a major player in the global fight against cancer?

At Trasis, we give you the opportunity to work with cutting-edge technologies and contribute to the improvement of cancer diagnosis and therapy techniques. Through your actions, you’ll be able to have a positive impact on the services provided to users and patients.

The opportunity to help build and improve processes in a fast-growing company.

We offer you a young and friendly working atmosphere, a flexible and dynamic environment.

An attractive, flexible salary based on your experience and performance, plus fringe benefits.

QC Microbiology Specialist

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QC Microbiology Specialist