Client & Role summary: My client is part of a global group and in this unit, they are producing OTC and other healthcare products. In this position, you will be responsible for Audit & Supplier Management and act like SME in this Quality unit.

YOUR TASKS

• As a senior QA, your main responsibility within our QM system is to ensure the qualification of external partners (e.g. suppliers, contract manufacturers). You will independently plan, carry out, document and track the necessary audits
• You will support projects to establish new contract manufacturers with a focus on method transfer and the associated validations with your in-depth know-how
• You ensure that our contract manufacturers comply with the requirements of the approval documentation for our medicines and check the manufacturing and testing regulations
• You will be involved in the creation and review of product quality reviews and the delineation of responsibility agreements
• As part of your activities, you will also manage change and CAPA processes and process deviations

YOUR PROFILE

• You can successfully complete a university degree in pharmacy, natural sciences or a similar qualification
• You are a qualified GMP auditor and are familiar with method validation and method transfer projects
• You have at least five years of relevant professional experience in quality assurance in the pharmaceutical industry, ideally with a focus on manufacturing and quality control
• 2-3 business trips per month are a welcome change from everyday office life for you
• You have in-depth knowledge of GMP regulations and current legislation (AMG, AMWHV).
• An analytical, precise and forward-looking working style, coupled with a creative approach, are a given for you
• Fluent in German & English

Application process:

CV and the references to my email: y.cakmak@sciproglobal.de

Call with a presentation of the company

I am your contact person for the entire application process (interviews to contract negotiations) i.e. You don't have to apply yourself

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