Für unseren Klienten, ein global agierendes Pharma-/Biotechunternehmen mit Standort in Biberach suchen wir einen:
Coordination Specialist (m/w/d)
Job Description:
- Providing the supply of clinical trials with pharmaceutical products according valid laws, GMP-formalities and quality-standards in agreed timelines and cost efficiency requirements for global phase I - IV clinical programs
- Study specific contact person for all packaging & labeling activities within internal packaging area for assigned projects and trials within trial team
- Ensures the timely provision of packaging related tasks of clinical supplies for assigned trials
- Packaging Labeling Coordination (PLC) in alignement with the trial team provides packaging related supply chain tasks and is primary contact of the packaging operation areas (internal)
- Creation and check of master batch records and packaging orders (including review)
- Providing of packaging & labeling documents for final release. Development and optimization of processes for packaging clinical trial supplies
- Ensure that all work is performed in a safe manner and in conformance with US, EU, German and other international regulations
- Accountability for a broad set of activities to enable and support numerous functions in Global CTSU including the maintenance of a number of interface relationships to ensure the efficiency of the CTSU/PLC responsibilities. The accountabilities require thorough planning as well as quick decision making in complex situations
Skills:
- Masters degree or equivalent in relevant scientific area or alternatively Bachelors degree or equivalent in relevant scientific area plus relevant experience
- Proven customer orientation across functions including sense of urgency and priority
- Project management capabilities and experience
- Capability for fast and focused decision making, including risk assessments, to deliver results, while driving for innovation and improvement
- Ability to interpret complex project requirements, associated regulations and highly complex experimental data to drive results in a changing environment
Könnte dies Ihre nächste Herausforderung sein? Ich freue mich auf Ihre Bewerbung!
Thomas Jin
Value Recruiter - Kelly Scientific Resources
089 384 090 7
thomas.jin[at]kellyservices.de
About Kelly
Kelly Services ist Ihr Spezialist für die Vermittlung von Fach- und Führungskräften. Wir bringen Sie mit genau dem Unternehmen zusammen, das zu Ihnen passt. Eine Vermittlung über uns ist persönlich, vertraulich und unkompliziert.
Unser Versprechen
Als Arbeitgeber, der für Chancengleichheit steht, begrüßen wir Bewerbungen aller entsprechend qualifizierten Personen, unabhängig von Geschlecht, sexueller Orientierung, Herkunft, Religion/Weltanschauung oder Alter. Informationen zum Umgang mit Ihren Daten finden Sie in unserer Datenschutzerklärung.
