We are currently looking for a QA Validation Specialist to join our client´s team in Düsseldorf. The Specialist Quality Validation is part of the QA Validation team and supports all qualification and validation activities, including equipment and utility qualification, validation of computerized systems, process validation, and method validation. Additionally, the QA Validation team collaborates closely with all departments (production, engineering, MS&T, quality control, etc.) and other QA functions to facilitate continuous improvement of quality processes and practices.

Responsibilities:

* Creating, reviewing, and approving qualification and validation-related documents.
* Ensuring that quality standards are applied in accordance with regulatory, company, and industry requirements.
* Contributing to the continuous improvement of GMP-related processes.
* Utilizing available eQMS tools and processes and coordinating with various stake-holders.

Requirements:

* A bachelor's degree or higher in biology, chemistry, engineering, quality, or production, or equivalent experience in the pharmaceutical industry.
* At least 3 years of relevant professional experience in quality assurance or qualification and validation. Experience with computerized system validation is desirable, as well as familiarity with biopharmaceutical production processes.
* A solid understanding of EU and U.S. cGMPs, industry, and regulatory standards and guidelines, along with a strong compliance mindset.
* Excellent communication and organizational skills.
* Attention to detail, exceptional problem-solving abilities, and critical thinking skills.
* Fluent proficiency in both German and English.