Specialist Quality Assurance GMP (m/w/d)

Specialist Quality Assurance GMP (m/w/d)

Location: Mainz-Bingen

Client: Office Events P & B GmbH

Job Category: Other

EU work permit required: Yes

Job Reference: d10a92468304

Job Views: 2

Posted: 21.06.2025

Expiry Date: 05.08.2025

Job Description:

• Process, assess, and decide on quality incidents during manufacturing, release, packaging/labelling, and distribution of investigational medicinal products (IMPs).
• Manage and drive different kinds of quality incidents with globally organized functional departments and external partners.
• Develop and improve internal quality processes and supporting IT systems.
• Present quality incidents in management meetings, audits, and inspections.
• Contribute to international and interdisciplinary quality working groups, ensuring deliverables are achieved.
• Require a Bachelor degree or professional training with additional qualification (e.g., "Industriemeister (m/w/d)").
• Have several years of practical experience in drug manufacturing, analytics, quality assurance, or development in the pharmaceutical industry.
• Possess advanced knowledge of development processes for investigational medicinal products and in-depth knowledge of cGMP regulations for IMPs.
• Have expert knowledge of health authorities’ requirements (cGMP regulations e.g., EU-GMP Guide, CFR).
• Demonstrate conceptual thinking, high customer focus, and result orientation.
• Exhibit strong oral and written communication skills in English and German.