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Quality Manager / Drug Safety Manager (60%) Pfäffikon Switzerland,  

Takeda (company)


Posted on : 19 September 2017

Project Description

Role Objective

  • Support Qualified Person in all aspects of Quality and Pharmacovigilance in accordance to Swiss regulations
  • Cooperation with different local and global functions
  • Reporting into LOC Quality Head / Drug Safety Officer


Accountabilities
  • Area Quality
  • Ensures Global Distribution Practice/Global Manufacturing Practice compliance in cross functional collaboration with Regulatory Affairs and Supply Chain
  • Performs local national release in accordance to Swiss requirements
  • Manages local deviations
  • Manages complaints with the manufacturing site and the global functions
  • Manages change requests in accordance with quality agreements
  • Qualification of customers and suppliers
  • Support Qualified Person in self-inspections, audits and authority inspections
  • Adaption and review of local SOPs
  • Support Qualified Person for mandatory trainings
  • Area Drug Safety
  • Manages safety information in Takeda local Pharma Covigilance unit (LOC) according to appropriate Standards and SOPs.
  • Monitors local Risk Management Plans (RMP) and risk minimization activities
  • Support Market Research (MR) and/or Patient Support Programs (PSPs) as local PV partner
  • Review local medical literature
  • Support

Locations

Pfaeffikon, Switzerland

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