Beschreibung
- In Pharmaceutical Research and Early Development organization (pRED), we make transformative medicines for patients in order to tackle some of the world’s toughest unmet healthcare needs. At pRED, we are united by our mission to transform science into medicine. Together, we create a culture defined by curiosity, responsibility and humility, where our talented people are empowered and inspired to bring forward extraordinary life-changing innovation at speed. This position is located in Preclinical Chemistry, Manufacturing, and Controls (pCMC), a department within the Small Molecule Research organization in pRED Therapeutic Modalities (TMo), where we pave, in a diverse, ambitious and innovative environment, the path to bring drug candidates from early research into development. We collaborate actively with our discovery and development partners functions providing cutting-edge technologies and scientific excellence to transform molecules into future medicines.
- We are CMC experts and build our strength on a broad diversity of technical expertise in chemistry, formulation design, material science and analytical chemistry, delivering and innovating in the space of small molecules, peptides and nucleic acid-based medicines.
- You have a Bachelor or equivalent and/or higher degree in chemistry, biology or pharmaceutical sciences or operational experience in a GMP environment within the pharmaceutical industry. Experience in synthetic molecule manufacturing and/or quality control, as well as knowledge of GMP regulations (e.g., ICH Guidelines) and principles of quality systems is a plus. You are fluent in German and have good verbal and written communication skills in English. You have a detail-oriented and analytical mindset with the ability to identify potential deficiencies, propose solutions, and effectively interpret and apply regulatory requirements. You demonstrate excellent communication skills and the ability to collaborate efficiently with interdisciplinary teams in a dynamic environment. You appreciate being empowered to make decisions in your own field of expertise and actively seek feedback from others.
GMP Compliance Specialist (m/f/d)
Reference: -en
Start: asap
Duration: 24 MM++
Main tasks:
- Management of local and global compliance processes like GMP training, archiving, quality risk management, handling of multisite and local impact assessments
- Being an expert and first level support for relevant quality systems e.g. Cornerstone, Veeva OneQMS, QualityDocs, QRM
- Managing changes and deviations, as well as corrective and preventive actions in consultation with QA
- Provide expert support to monitor, update, and adapt the GMP-relevant document landscape within pCMC
- Participating in the preparation and coordination of internal and health authority audits, as well as supporting the timely implementation of inspection findings
- Collaborating with team members in a role based working environment, as well as building and growing relationships with customers and partners across functional boundaries
Main qualifications
- Bachelor or equivalent and/or higher degree in chemistry, biology or pharmaceutical sciences
- Operational experience in a GMP environment within the pharmaceutical industry
- MS office or standard Google applications
- Fluent in German, good verbal and written communication skills in English
- Detail-oriented and analytical mindset; ability to identify potential deficiencies, propose solutions, and effectively interpret and apply regulatory requirements; excellent communication skills; ability to collaborate efficiently with interdisciplinary teams in a dynamic environment.
Main advantages:
- A very renowned company
- You will work in an international environment
About us:
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
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My contact person:
Konstantina Glykou
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