Quality Assurance Manager

vor 1 Monat


Basel, Schweiz FLEXSIS Vollzeit
EINFÜHRUNG:
As a preferred supplier for Roche in Basel, we are looking for an individual Quality Assurance Manager (m/f/d)This is a full/part-time position (80-100%) with a 3-year project duration. The ideal start date is asap or 01.03.2025. Home Office is possible up to 40% (Monday and Wednesday onsite days). AUFGABENBESCHREIBUNG:
  • You have end-to-end quality oversight on the qualified state of all assets in your assigned area.
  • You provide fit for purpose quality support for all the activities related to qualification & CSV, calibration, maintenance & reliability engineering.
  • You review and approve GMP records that cover technical change management, deviation management & CAPAs, risk assessments and SOPs.
  • You coordinate and facilitate complex investigations, root cause analyses, technical risk assessments, and continuous improvement projects.
  • With your operations partner you present topics during health authority inspections and internal audits.
ERFORDERLICHES PROFIL:
  • University degree in science or engineering
  • Min. 3 years demonstrated experience in Quality Assurance at a pharmaceutical manufacturing site
  • Practical experience in commissioning & qualification projects in highly automated GMP production facilities
  • Well established confidence in setting precise guidance for QA compliance in technical changes, deviations and CAPAs
  • Your collaboration with partners is characterized by outstanding communication and team work.
  • You manage to drive quality awareness with operations partners at all levels by integrating regulatory requirements, analytical problem solving and scientific rationale.
  • Excellent German and English language skills, both written and spoken.
Application process Interested? You can find more information here:

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