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OCOctapharma

Lead Expert Quality Assurance, Deputy Responsible Person(m/w/x)

Lachen
Part-timeOn-siteSenior

You will play a vital role in ensuring product safety and compliance by managing market releases, liaising with Swissmedic, and overseeing diverse quality assurance and pharmacovigilance tasks.

Requirements

  • Master's degree in pharmaceutical or life sciences
  • Preferably several years of pharmaceutical industry experience
  • Experience in a Quality Unit if possible
  • Advantageous experience in Regulatory affairs or Pharmacovigilance
  • Excellent organizational and project management skills
  • Drive for excellence and positive approach
  • Exactness, accuracy, and eye for detail
  • Confidence to provide support when needed
  • Fluent German and very good English
  • Basic written and spoken French as a plus

Tasks

  • Perform compliance checks on Swiss market batches
  • Execute administrative market releases for products
  • Liaise between Swissmedic and Corporate Regulatory departments
  • Maintain and organize new marketing authorizations
  • Act as Deputy Local Drug Safety Officer
  • Fulfill pharmacovigilance requirements for Switzerland and Liechtenstein
  • Manage the Document Management System
  • Conduct internal audits and employee training
  • Handle change controls, deviations, and CAPA
  • Review returns and Product Quality Reports
  • Qualify various service providers
  • Assume Responsible Person duties during their absence
  • Ensure compliance with Swiss laws and EU guidelines
  • Uphold standards within the Swissmedic Establishment License

Work Experience

approx. 4 - 6 years

Education

Master's degree

Languages

GermanBusiness FluentEnglishBusiness FluentFrenchBasic

Benefits

Learning & Development

  • Internal and external trainings
  • Leadership trainings
  • Trainee programs

Modern Equipment

  • Digital solutions
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