Quality Engineer (m / f / d)

On behalf of our client AbbVie , we are looking for a Quality Engineer for the Ludwigshafen site. If you combine analytical thinking with organizational skills and would like to play an active role in shaping quality assurance for investigational medicinal products, we can offer you a challenging and varied role.

Here’s what we offer

• Attractive salary and long-term job security through group affiliation
• Up to 30 days vacation per year
• Contribution to company pension scheme after end of probationary period
• Extensive social benefits, including Christmas and vacation bonuses

Your tasks

• GMP-compliant complaint management for investigational medicinal products
• Independent performance of tests
• Timely coordination of laboratory analyses
• Preparation of investigation reports and participation in root cause analysis (RCA)
• Definition of CAPAs and pharmaceutical risk assessment
• Administrative support for the release of investigational medicinal products
• Preparation of documents for import / export and clinical trial applications (CTA)
• Management of manufacturing and import authorization amendments (MIA)
• Preparation of submission documents (e.g. QP declaration, pedigrees, BSE / TSE)

Your profile

• Degree in natural sciences (university / university of applied sciences).
• Several years of experience in the pharmaceutical industry (QA, manufacturing, QC).
• Profound experience in drug development and clinical trial management.
• Comprehensive knowledge of cGMP (EU / US), Clinical Trial Regulation (CTR) and international pharmaceutical law.
• Business fluent in written and spoken English.
• Strong organizational skills, assertiveness and problem-solving skills.
• Working style : Strong analytical, team-oriented and experienced in intercultural collaboration.

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