(Senior) GMP Compliance Specialist | (Senior) GMP Compliance Specialist (m/w/d)
QIAGEN GmbH
Job Summary
As a (Senior) GMP Compliance Specialist at QIAGEN, you will play a critical role in ensuring the safety, stability, and regulatory compliance of chemical and biotechnological manufacturing processes. Your daily responsibilities involve drafting and maintaining SOPs, manufacturing instructions, and risk analyses within a strict Change Control framework. You will actively participate in the qualification and validation of processes and systems while continuously refining hygiene and cleaning standards. Collaboration is key, as you will work closely with production, development, and quality assurance teams to prepare for and support internal, customer, and regulatory audits. This position is ideal for a quality-driven professional who enjoys a mix of technical documentation and hands-on process optimization. QIAGEN offers an attractive package including hybrid work options, a bonus scheme, and professional development through their internal academy, making it an excellent environment for career growth in the life sciences sector.
Required Skills
Education
University degree in Natural Sciences or Engineering (Biology, Biochemistry, Biotechnology, or Chemistry).
Experience
- Professional experience in a regulated environment such as IVD, medical devices, or the pharmaceutical industry
- Experience with quality standards including ISO 13485, ISO 18385, and 21 CFR 820
- Proven experience in creating and managing GMP-relevant documentation and SOPs
- Experience in preparing and accompanying audits and regulatory inspections
Languages
Additional
- The role requires strong organizational and coordination skills. Experience with generative AI is noted as a beneficial asset. The position is full-time and permanent (unbefristet).
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