Quality Assurance Operations III (m/f/d)

Firmenname für PREMIUM-Mitglieder sichtbar

  • August 2021
  • nicht angegeben
  • CH-Solothurn
  • auf Anfrage
  • 22.07.2021
  • 556497/1-en

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Projektbeschreibung

Ihre Aufgaben:
• Acts as Quality contact for closure of exceptions, CAPAs and change controls related to Quality systems (including IT Quality systems)
• Support process improvements related to GxP activities,by providing quality oversight
• Participate as a GEQ Quality Systems representative on cross-functional teams and projects
• Give advice on regulatory and compliance question to stakeholders
• Address potential gaps for processes or practices within teams and projects to avoid incompliance
• Support general support in Program Management activities, including collection fo data for monthly reports, Management Reviews and follow up of action items
• Support site compliance activities such as advising other departments on GxP compliance aspects, managing preparation for, and follow-up of audits and inspection

Ihre Qualifikationen:
• Master Degree / Bachelor Degree in scientific field + experience in relevant industry or equivalent
• Quality experience in the pharmaceutical industry
• Knowledge of cGMP requirements, EU/FDA regulations and compliance
• Experience in IT systems qualification & project management
• In-depth understanding and thorough knowledge of the area of work and related quality disciplines (mainly EU and US GxP, applicable regulatory requirements)
• Technical and/or scientific insight in the design and execution of processes and procedures
• Project management experience (six sigma)
• Knowledge of Oracle PLM, Trackwise or agility in using IT systems is a plus

Ihre Vorteile:
• A very renowned company
• Possibility of extension

Projektdauer: 12 MM++





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