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Senior Expert Fill & Finish / FDA Inspection Readiness (M/F/D))
Tasks:
Provide expert support to the production department in preparation for FDA inspections
Conduct GMP and FDA readiness assessments and identify regulatory/compliance gaps
Support the implementation of measures to close identified compliance gaps
Review and optimize GMP-relevant documentation, including SOPs, batch records, logbooks and risk assessments
Assess and support the management of deviations, CAPAs, Change Controls and OOS/OOT events with regard to FDA expectations
Advise on current FDA requirements and implementation of EU GMP requirements, particularly Annex 1
Conduct shopfloor assessments and coach employees where required
Prepare presentations and supporting materials for FDA inspection readiness
Independently manage and close CAPAs
Support the production organization before and during FDA inspections
Qualification:
Degree in Pharmacy, Biotechnology, Process Engineering, Chemistry or a comparable qualification preferred
Minimum 10 years of practical experience in sterile pharmaceutical manufacturing within a GMP-regulated environment
Several years of hands-on operational experience in aseptic filling and lyophilization (Fill & Finish)
Proven experience preparing for and supporting successful FDA inspections in sterile manufacturing environments
Very good knowledge of FDA requirements, particularly 21 CFR Parts 210/211, EU GMP guidelines and Annex 1
Strong knowledge of aseptic manufacturing processes, including sterile filtration, isolator technology, cleanroom classification, Environmental Monitoring, Media Fills (APS) and Contamination Control Strategy (CCS)
Strong knowledge of GMP documentation, deviation management, CAPA, Change Control, qualification and validation
Experience handling inspection observations and implementing sustainable compliance measures
Very good German and English skills
Strong communication and consulting skills, with the ability to work closely with production and quality teams
Requirements:
Start: 01.09.2026
Duration: 6 months
Capacity: 5 days per week
Location:Germany; remote work possible by arrangement, max. 1 day per week
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