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QA Sterility Assurance Manager 80-100%

CH - Stein💼 Full-time🗓 2026-09-08 → 2026-09-26

Core

Lead sterility assurance, contamination control, and quality excellence for sterile manufacturing to safeguard patient safety.

Role type

Senior IC sterility assurance manager

Builds

Sterile medicines and therapies

Domain

Life sciences / Pharmaceutical manufacturing

Deliverable

production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work

Required skills

EU GMP Annex 1 expertise, Contamination Control Strategy (CCS) development, aseptic processing, media fills (APS), contamination risk management, root cause analysis, regulatory inspection readiness

Preferred skills

German language proficiency, audit experience

Technologies

None stated

Responsibilities

Lead sterility assurance strategy and CCS enhancement; support facility design, qualification, validation, and technology transfers; champion quality culture via risk assessments and training; represent QA during inspections and audits

Seniority

Senior, hands-on IC

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