Responsibilities:

• Processing, monitoring, maintenance and optimization of the central quality assurance systems (change control, deviations, CAPA, OOS, complaints)
• Creation, review, monitoring and approval of standard operating procedures (SOPs)
• Review of quality-relevant documents (qualification and validation reports, risk analyses, specifications, batch documentation, manufacturing and testing instructions)
• Creating Product Quality Reviews
• Review and creation of Quality Agreements
• Conducting self-inspections and supplier audits
• Support in the qualification of production facilities/equipment and suppliers/service providers
• Answering customer inquiries (e.g. processing questionnaires)
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