Oberbayern: Validation Expert (m/w/d) – Pharma
Our client, a manufacturer of innovative transdermal drug delivery systems, is looking for a:
Validation Expert (m/w/d)
Responsabilities:
- 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
Profil:
- 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
chaumont@triga-consutting.de
+49-(0)89-809130720
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