Our client, a manufacturer of innovative transdermal drug delivery systems, is looking for a:
Validation Expert (m/w/d)
Aufgaben
* Planning, execution, and documentation of qualification activities (IQ, OQ, PQ) for rooms, equipment, processes, and media
* Organization and implementation of re-qualifications in accordance with current regulations
* Creation and maintenance of GMP-relevant documents, including URS, qualification plans, reports, and SOPs
* Ensuring compliance with legal requirements and internal company standards
* Coordination of internal and external processes, including qualifications, calibrations, supplier qualifications, as well as handling deviations and CAPA measures
* Continuous improvement and optimization of qualification processes
Qualifikation
* Completed studies in pharmaceutical engineering, process engineering, engineering sciences, or a comparable field
* Several years of experience in GMP qualification/validation
* Sound knowledge of current GMP regulations, especially Annex 15, as well as relevant ISO and DIN standards
* Experience in planning and implementing qualification and validation projects, change management, as well as project management and coordination
* Very good German and good English skills
* Strong team spirit, excellent communication skills, and analytical thinking
* Independent and structured working style with strong conceptual skills
* Proficiency in Microsoft Office and SAP
Benefits
* Attractive salary
* Travel cost allowance
* Subsidy for capital-forming benefits and retirement provision
* In-house cafeteria
* EGYM Wellpass
* Internal and external training opportunities
* Business bike leasing
* Free access to the Babbel language learning platform
* Corporate health management
* An open and positive work environment
Contact:
Mariana Chaumont
Senior Consultant
+49-(0)89-809130720
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