Informationen zur Anzeige:
Specialist Quality Assurance GMP (m/w/d)
Office Events P & B GmbH
Mainz am Rhein (DE)
Aktualität: 09.05.2024
Anzeigeninhalt:
09.05.2024, Office Events P & B GmbH
Mainz am Rhein (DE)
Specialist Quality Assurance GMP (m/w/d)
- in your new role as Specialist Quality Assurance GMP you process, assess, and decide on quality incidents during manufacturing, release, packaging/labelling, and distribution of investigational medicinal products (IMPs)
- You manage and drive different kinds of quality incidents together with globally organized functional departments and with external partners
- additionally, you further develop and improve the internal quality processes and the supporting IT systems
- You are responsible to present quality incidents in management meetings, audits, and inspections
- in addition, you contribute to international and interdisciplinary quality working groups and ensure that deliverables are achieved
- Bachelor degree or professional training with additional qualification (e. g. "Industriemeister (m/w/d)")
- several years of practical and proven experience in drug manufacturing or analytics, quality assurance and/or development in the pharmaceutical industry
- advanced knowledge of development processes for investigational medicinal products as well as in-depth knowledge of cGMP regulations for IMPs
- expert knowledge of health authorities' requirements (cGMP regulations e.g., EU-GMP Guide, CFR etc.)
- conceptual thinking, high customer focus and result orientation
- strong oral and written communication skills in English and German
Standorte