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.
