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Description

The Opportunity

This position is for those already experienced in pharmaceutical sterility testing to GMP standards and is a great new role that will be instrumental to the continuing success of the microbiology testing teams.

Reporting into the Microbiology manager and acting as subject matter expert you will work closely with a mix of microbiologists and the quality team. Supporting the QC functions, this is a brand new role created to provide technical support, specialist knowledge and troubleshooting advice to the rest of the microbiology team.

Your main responsibilities will consist of method validation and development, troubleshooting problems and providing recommendations and conducting in depth microbiology investigations some of which will be complex.

Collaborating with management you will also contribute to continuous improvement, process mapping to identify efficiencies, using tools such as fishbone diagrams to determine root cause of any out of spec results and working with QAy on CAPAs and change controls. All this will be in accordance to GMP/GLP, FDA standards and USP guidelines.

About You

To apply for this exciting new position you should demonstrate considerable experience in pharmaceutical microbiology to GMP standards, particularly with significant knowledge of sterility testing requirements (USP 71, EP 2.6.1) on top of a relevant scientific degree.

In addition, you should have proven:

• Troubleshooting, method development and investigations experience.
• Strong analytical, problem solving and communication skills as you will organise and present data on investigations to senior management, regulatory agencies, clients, etc.
• Strong interpersonal skills and an ability to work both independently and collaboratively at all levels

Experience with the use of improvement tools such as process flows and gap assessments would be highly desirable.

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